Ophthalmic Device FDA Registration

US FDA Registration

 

OPHTHALMIC DEVICES

( Non-active Class I devices)

 

Ophthalmic devices are designed to prevent and potential eye damage, disease or any injuries. Ophthalmic devices covers the various design types and applications such as glasses, intraocular lenses, diagnostics, contact lenses, implants, lasers, solutions and surgical instruments. As per FDA Ophthalmic devices are classified under part 886 as Diagnostic devices, Prosthetic devices, Surgical devices and Therapeutic devices.

 

Product code  
HJC Device Name  Esthesiometer, Ocular
Class 1
Regulation Name  

Ocular esthesiometer

 

 

Regulation No.

 

 

886.1040

Identification An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity
Status 510(K) Exempt
 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HOX Device Name  

Chart, Visual Acuity

 

Class  

1

 

Regulation Name  

Visual acuity chart.

 

 

 

 

Regulation No.

 

 

 

886.1150

 

Identification  

A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HIT Device Name  

Tester, Color Vision

 

Class  

1

 

Regulation Name  

Color vision tester

 

 

 

Regulation No.

 

 

886.1170.

 

Identification  

A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 

 

 

HMT Device Name Distometer
Class 1
Regulation Name Distometer
 

 

Regulation No.

 

 

 

 

886.1190

 

 

Identification  

A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HOW Device Name  

Drum, Opticokinetic

 

Class  

1

 

Regulation Name  

Optokinetic drum

 

 

Regulation No.

 

886.1200
Identification  

An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HLS Device Name  

Exophthalmometer.

 

Class  

1

 

Regulation Name  

Exophthalmometer.

 

 

Regulation No.

 

886.1270
Identification  

An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball).

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HKG Device Name  

Fornixscope

 

Class  

1

 

Regulation Name  

Fornixscope

 

 

Regulation No.

 

886.1320.
Identification  

A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HOQ Device Name  

Grid, Amsler

 

Class 1

 

Regulation Name  

Amsler grid

 

 

Regulation No.

 

886.1330.
Identification  

An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

 

 
HPD Device Name  

Lens, Bagolini

 

Class  

1

 

Regulation Name  

Bagolini lens

 

 

Regulation No.

 

 

886.1375

 

 

Identification  

A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HJL Device Name Lens, Condensing, Diagnostic
Class  

1

 

Regulation Name Diagnostic condensing lens
 

Regulation No.

 

886.1380
Identification  

A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HJI Device Name  

Lens, Fundus, Hruby, Diagnostic

 

 

Class

 

1
 

Regulation Name

 

Diagnostic Hruby fundus lens.
 

Regulation No.

 

886.1395
Identification  

A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HKR Device Name  

Lens, Maddox

 

 

Class

 

1
 

Regulation Name

 

Maddox lens.
 

Regulation No.

 

886.1400
Identification  

A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intended to be handheld or placed in a trial frame to evaluate eye muscle dysfunction.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HPC Device Name  

Set, Lens, Trial, Ophthalmic

 

 

Class

 

1
 

Regulation Name

 

Ophthalmic trial lens set
 

Regulation No.

 

886.1405
Identification  

An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HPB Device Name  

Clip, Lens, Trial, Ophthalmic

 

 

Class

 

1
 

Regulation Name

 

Ophthalmic trial lens clip
 

Regulation No.

 

886.1410
Identification  

An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HPA Device Name  

Frame, Trial, Ophthalmic

 

 

Class

 

1
 

Regulation Name

 

Ophthalmic trial lens frame.
 

Regulation No.

 

886.1415
Identification  

An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HLN Device Name  

Gauge, Lens, Ophthalmic

 

 

Class

 

1
 

Regulation Name

 

Ophthalmic lens gauge.
 

Regulation No.

 

886.1420
Identification  

An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HLC Device Name  

Instrument, Measuring, Stereopsis

 

 

Class

 

1
 

Regulation Name

 

Stereopsis measuring instrument
 

Regulation No.

 

886.1460
Identification  

A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HKF

 

 

 

 

 

 

Device Name  

Instrument, Measuring, Stereopsis

 

 

Class

 

1
 

Regulation Name

 

Headband mirror
 

Regulation No.

 

886.1500.
Identification  

A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

 

HKW

 

 

 

 

 

 

Device Name  

Prism, Bar, Ophthalmic

 

 

Class

 

1
 

Regulation Name

 

Ophthalmic bar prism
 

Regulation No.

 

886.1650
Identification  

An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient’s eyes.

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

 

HKT

 

 

 

 

 

 

Device Name Prism, Fresnel, Ophthalmic
 

Class

 

1
 

Regulation Name

 

Ophthalmic Fresnel prism
 

Regulation No.

 

886.1655
Identification  

An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

 

HKS

 

 

 

 

 

 

Device Name Prism, Gonioscopic
 

Class

 

1
 

Regulation Name

 

Gonioscopic prism.
 

Regulation No.

 

886.1660
Identification A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HKQ

 

 

 

 

 

 

Device Name Prism, Rotary, Ophthalmic
 

Class

 

1
 

Regulation Name

 

Ophthalmic rotary prism
 

Regulation No.

 

886.1665
Identification An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HMH

 

 

 

 

 

 

Device Name Prism, Rotary, Ophthalmic
 

Class

 

1
 

Regulation Name

 

Skiascopic rack
 

Regulation No.

 

886.1750
Identification A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HKN

 

 

 

 

 

 

Device Name Prism, Rotary, Ophthalmic
 

Class

 

1
 

Regulation Name

 

 Manual refractor
 

Regulation No.

 

 886.1770.
Identification A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HKN

 

 

 

 

 

 

Device Name Refractor, Manual, Non-Powered, Including Phoropter
 

Class

 

1
 

Regulation Name

 

Manual refractor
 

Regulation No.

 

886.1770.
Identification A manual refractor is a device that is a set of lenses of various dioptric powers intended to measure the refractive error of the eye.
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HLE

 

 

 

 

 

 

Device Name Ruler, Nearpoint (Punctometer)
 

Class

 

1
 

Regulation Name

 

Nearpoint ruler.
 

Regulation No.

 

 886.1790
Identification A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum).
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

KYD

 

 

 

 

 

 

Device Name Strip, Schirmer
 

Class

 

1
 

Regulation Name

 

Schirmer strip.
 

Regulation No.

 

 886.1800
Identification A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient’s lower eyelid to stimulate and evaluate formation of tears.
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 
 

 

 

 

 

 

 


HOR

 

 

 

 

 

 

Device Name Simulatan (Including Crossed Cylinder)
 

Class

 

1
 

Regulation Name

 

Simulatan (including crossed cylinder).
 

Regulation No.

 

 886.1840
Identification  

A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in focus, as the examiner uses different lenses).

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 


HLP

 

 

 

 

 

 

Device Name Target, Fusion And Stereoscopic
 

Class

 

1
 

Regulation Name

 

Fusion and stereoscopic target
 

Regulation No.

 

 886.1880
Identification A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (886.1870).
Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

 

 
 

 

 

 

 

 

 


HKD

 

 

 

 

 

 

Device Name Tape, Nystagmus
 

Class

 

1
 

Regulation Name

 

Nystagmus tape.
 

Regulation No.

 

 886.1905
Identification  

Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient’s field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

NCK

 

 

 

 

 

 

 

 

Device Name Button, Iris, Eye, Artificial
 

Class

 

1
 

Regulation Name

 

Artificial eye
 

Regulation No.

 

 

886.3200

Identification  

An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient’s eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

HQH

 

 

 

 

 

 

 

 

Device Name Eye, Artificial, Non-Custom
 

Class

 

1
 

Regulation Name

 

Artificial eye
 

Regulation No.

 

 

886.3200

Identification  

An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient’s eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 

 
 

 

 

 

 

 

 

HQJ

 

 

 

 

 

Device Name Implant, Absorbable, (Scleral Buckling Methods)
 

Class

 

1
 

Regulation Name

 

Absorbable implant (scleral buckling method)
 

Regulation No.

 

 

886.3300

Identification  

An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 

 
 

 

 

 

 

 

 

HMS

 

 

 

 

 

Device Name Drum, Eye Knife Test
 

Class

 

1
 

Regulation Name

 

 

Ophthalmic knife test drum

 

Regulation No.

 

 886.4230.
Identification  

An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

MSS

 

 

 

 

 

Device Name Folders And Injectors, Intraocular Lens (Iol)
 

Class

 

1
 

Regulation Name

 

 

Intraocular lens guide

 

 

Regulation No.

 

 886.4300
Identification  

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

 

Status 510(k)
Remarks NIL
 
 

 

 

 

 

 

 

OTZ

 

 

 

 

Device Name  

 

Graft Insertion Instrument For Endothelial Keratoplasty

 

 

Class

 

1
 

Regulation Name

 

 

Intraocular lens guide

 

 

Regulation No.

 

 886.4300
Identification  

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

 

Status 510(k)
Remarks  

A graft insertion device for endothelial keratoplasty functions as a protective guide for the insertion of a donor corneal graft through a corneal incision. Once the graft tissue has been loaded into the insertion device, the device is inserted through the corneal incision in the subject’s eye. Once in the eye, the operator can then releases or dispenses the tissue graft from the device. Following graft release, the graft insertion device is removed.

 

 
 

 

 

 

 

 

 

NCE

 

 

 

 

Device Name Injector, Capsular Tension Ring
 

Class

 

1
 

Regulation Name

 

 

Intraocular lens guide

 

 

Regulation No.

 

 886.4300
Identification  

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

 

Status 510(k)
Remarks  

NIL

 

 
 

 

 

 

 

 

 

KYB

 

 

 

 

Device Name Lens, Guide, Intraocular
 

Class

 

1
 

Regulation Name

 

 

Intraocular lens guide

 

 

Regulation No.

 

886.4300
Identification  

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HOF

 

 

 

 

Device Name Burr, Corneal, Manual
 

Class

 

1
 

Regulation Name

 

 

Manual ophthalmic surgical instrument

 

 

Regulation No.

 

886.4350
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HOE

 

 

 

 

Device Name Caliper, Ophthalmic
 

Class

 

1
 

Regulation Name

 

 

Manual ophthalmic surgical instrument

 

 

Regulation No.

 

886.4350
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

HMX

 

 

 

 

Device Name Cannula, Ophthalmic
 

Class

 

1
 

Regulation Name

 

 

Manual ophthalmic surgical instrument

 

 

Regulation No.

 

886.4350
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

 
 

 

 

 

 

 

 

MXY

 

 

 

 

Device Name Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
 

Class

 

1
 

Regulation Name

 

 

Manual ophthalmic surgical instrument

 

 

Regulation No.

 

886.4350
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

 

 

 

NGY

 

 

 

 

Device Name Cannula, Trocar, Ophthalmic
 

Class

 

1
 

Regulation Name

 

 

Manual ophthalmic surgical instrument

 

 

Regulation No.

 

886.4350
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

QGJ

 

 

 

 

Device Name Corneal Inlay Inserter Handle
 

Class

 

1
 

Regulation Name

 

 

Corneal inlay inserter handle.

 

Regulation No.

 

886.4355
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

QGJ

 

 

 

 

Device Name Corneal Inlay Inserter Handle
 

Class

 

1
 

Regulation Name

 

 

Corneal inlay inserter handle.

 

Regulation No.

 

886.4355
Identification  

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

KYG

 

 

 

 

Device Name Device, Irrigation, Ocular Surgery
 

Class

 

1
 

Regulation Name

 

Ocular surgery irrigation device.
 

Regulation No.

 

886.4360
Identification  

An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

FTZ

 

 

 

Device Name Locator, Magnetic
 

Class

 

1
 

Regulation Name

 

Permanent magnet
 

Regulation No.

 

886.4445.
Identification  

A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
 

 

 

 

HPN

 

 

 

Device Name Magnet, Permanent
 

Class

 

1
 

Regulation Name

 

Permanent magnet
 

Regulation No.

 

886.4445.
Identification  

A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

 

Status 510(k) exempt
Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement.

 
HMR Device Name  

Marker, Ocular

 

Class  

1

 

Regulation Name  

Ophthalmic surgical marker

 

 

Regulation No.

 

 

886.4570

 

Identification  

An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HMQ Device Name Marker, Sclera
Class  

1

 

Regulation Name  

Ophthalmic surgical marker

 

 

Regulation No.

 

 

886.4570

 

Identification  

An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HRP Device Name Pen, Marking, Surgical
Class  

1

 

Regulation Name  

Ophthalmic surgical marker

 

 

Regulation No.

 

 

886.4570

 

Identification  

An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
MOE Device Name Collagen Corneal Shield
Class  

1

 

 

Regulation Name  

Ophthalmic eye shield

 

 

 

Regulation No.

 

 

886.4750

Identification  

An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HOY Device Name  

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

 

Class  

1

 

 

Regulation Name  

Ophthalmic eye shield

 

 

 

Regulation No.

 

 

886.4750

Identification  

An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

 

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HOH Device Name  

Spectacle, Operating (Loupe), Ophthalmic

 

Class  

1

 

 

Regulation Name  

Ophthalmic operating spectacles (loupes)

 

 

 

Regulation No.

 

 

886.4770

Identification  

Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.

Status  

510(K) Exempt

 

 

Remarks

 

 

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

 
HJH Device Name  

Loupe, Binocular, Low Power

 

Class  

 

1

 

 

Regulation Name  

Low-power binocular loupe

 

 

 

Regulation No.

 

 

886.5120

Identification  

A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

KYE Device Name  

Inserter/Remover Contact Lens

Class  

 

1

 

 

Regulation Name  

Contact lens inserter/remover

 

 

 

Regulation No.

 

 

886.5420

Identification  

A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HJF Device Name  

Magnifier, Hand-Held, Low-Vision

 

Class  

 

1

 

 

Regulation Name  

Low-vision magnifier

 

 

 

Regulation No.

 

886.5540
Identification  

A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HKC Device Name  

Spectacle Microscope, Low-Vision

 

Class  

1

 

Regulation Name  

Low-vision magnifier

 

 

Regulation No.

 

886.5540
Identification  

A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HJZ Device Name  

Crutch, Ptosis

 

Class  

 

1

 

 

Regulation Name  

Ptosis crutch

 

 

 

Regulation No.

 

 

 

886.5600

 

Identification  

A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HJY Device Name Reader, Bar, Ophthalmic
Class  

1

 

Regulation Name  

Ophthalmic bar reader

 

 

Regulation No.

 

886.5800.

Identification  

An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HJX Device Name Reader, prism, Ophthalmic
Class  

1

 

Regulation Name  

Ophthalmic prism reader.

 

 

 

Regulation No.

 

 

 

886.5810

 

Identification  

An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

PLX Device Name Tear Duct Occluder
Class  

1

 

Regulation Name  

Nasolacrimal compression device

 

 

 

 

Regulation No.

 

 

 

886.5838

 

Identification  

A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HOI Device Name Spectacle, Magnifying
Class  

1

 

Regulation Name  

Magnifying spectacles

 

 

 

Regulation No.

 

886.5840.
Identification  

Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HQZ Device Name Frame, Spectacle
Class  

1

 

Regulation Name  

Spectacle frame.

 

 

Regulation No.

 

886.5842
Identification  

A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

NAI Device Name Lens, Prescription, Color Deficiency
Class  

1

 

Regulation Name  

Prescription spectacle lens

 

 

 

Regulation No.

 

886.5844
Identification  

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

NJH Device Name Lens, Spectacle (Prescription), For Reading Discomfort
Class  

1

 

Regulation Name  

Prescription spectacle lens

 

 

 

Regulation No.

 

886.5844
Identification  

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HQG Device Name Lens, Spectacle, Non-Custom (Prescription)
Class  

1

 

Regulation Name  

Prescription spectacle lens

 

 

 

Regulation No.

 

886.5844
Identification  

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HQY Device Name Sunglasses (Non-Prescription Including Photosensitive)
Class  

1

 

Regulation Name  

Sunglasses (non-prescription)

 

 

 

Regulation No.

 

886.5850
Identification  

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HKB Device Name  

Telescope, Hand-Held, Low-Vision

 

 

Class  

1

 

Regulation Name  

Low-vision telescope

 

 

 

Regulation No.

 

886.5870
Identification  

A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

HKK Device Name  

Telescope, Spectacle, Low-Vision

 

 

Class  

1

 

Regulation Name  

Low-vision telescope

 

 

 

Regulation No.

 

886.5870
Identification  

A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.

 

Status  

510(K) exempt

 

Remarks  

This class I device is exempt from the premarket notification procedures in subpart E of part 807. FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement

 

OPHTHALMIC DEVICES

(Non-active Class II devices)

Ophthalmic devices are designed to prevent and potential eye damage, disease or any injuries. Ophthalmic devices covers the various design types and applications such as glasses, intraocular lenses, diagnostics, contact lenses, implants, lasers, solutions and surgical instruments. As per FDA Ophthalmic devices are classified under part 886 as Diagnostic devices, Prosthetic devices, Surgical devices and Therapeutic devices.

 

Product code  
HJK Device Name  

Lens, Contact, Polymethylmethacrylate, Diagnostic

 

 

Class

 

2
 

Regulation Name

 

Polymethylmethacrylate (PMMA) diagnostic contact lens
 

Regulation No.

 

886.1385
Identification  

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

 

Status 510(k)
Remarks NIL
 
 

NYK

Device Name  

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

 

 

Class

 

2
 

Regulation Name

 

Polymethylmethacrylate (PMMA) diagnostic contact lens
 

Regulation No.

 

 

886.1385

Identification  

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

 

Status 510(k)
Remarks NIL
 
HJJ

 

Device Name  

Flexible diagnostic Fresnel lens.

 

 

Class

 

2
 

Regulation Name

 

Lens, Fresnel, Flexible, Diagnostic
 

Regulation No.

 

886.1390
Identification  

A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the lens of the eye)

 

Status 510(k)
Remarks NIL
 
 

 

 

 

 

 

 


PLZ

 

 

 

 

 

 

Device Name Ocular Pattern Recorder
 

Class

 

2
 

Regulation Name

 

Diurnal pattern recorder system.
 

Regulation No.

 

886.1925
Identification A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
Status 510(k)
Remarks  

NIL

 

 
 

 

 

 

 

 

 


HLA

 

 

 

 

 

 

Device Name Calibrator, Tonometer
 

Class

 

2
 

Regulation Name

 

Tonometer and accessories
 

Regulation No.

 

886.1930
Identification  

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

 

Status 510(k)
Remarks  

NIL

 
 

 

 

 

 

 

 


HPK

 

 

 

 

 

 

Device Name Tonograph
 

Class

 

2
 

Regulation Name

 

Tonometer and accessories
 

Regulation No.

 

886.1930
Identification  

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

 

Status 510(k)
Remarks  

NIL

 
 

 

 

 

 

 

 


NJJ

 

 

 

 

 

 

Device Name Tonometer, Analyzer, Ocular Blood Flow
 

Class

 

2
 

Regulation Name

 

Tonometer and accessories
 

Regulation No.

 

886.1930
Identification  

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

 

Status 510(k)
Remarks  

Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product classificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.

 

 
 

 

 

 

 

 

 


HKY

 

 

 

 

 

 

Device Name Tonometer, Manual
 

Class

 

2
 

Regulation Name

 

Tonometer and accessories
 

Regulation No.

 

886.1930
Identification  

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Status 510(k)
Remarks  

NIL

 

 
 

 

 

 

 

HQW

 

 

 

 

 

 

 

 

Device Name Clip, Tantalum, Ophthalmic
 

Class

 

2
 

Regulation Name

 

Ophthalmic tantalum clip
 

Regulation No.

 

886.3100
Identification  

An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.

 

Status 510(k) exempt
Remarks  

Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

 

 
 

 

 

 

 

HQN

 

 

 

 

 

 

 

 

Device Name Conformer, Ophthalmic
 

Class

 

2
 

Regulation Name

 

Ophthalmic conformer
 

Regulation No.

 

886.3130.
Identification  

An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

 

Status 510(k) exempt
Remarks  

Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

 

 
 

 

 

 

 

NQB

 

 

 

 

 

 

 

 

Device Name Conformer, Ophthalmic, Biological Tissue
 

Class

 

2
 

Regulation Name

 

Ophthalmic conformer
 

Regulation No.

 

886.3130.
Identification  

An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

 

Status 510(k) exempt
Remarks  

The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.

 

 

Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

 

 
 

 

 

 

 

NXM

 

 

 

 

 

 

 

 

Device Name Prosthesis, Eyelid Spacer/Graft, Biologic
 

Class

 

2
 

Regulation Name

 

 

 

Ophthalmic conformer

 

 

Regulation No.

 

 

886.3130

Identification  

An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

 

Status 510(k) exempt
Remarks  

Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

 

 
 

 

 

 

 

 

 

NFM

 

 

 

 

 

Device Name Expander, Tissue, Orbital
 

Class

 

2
 

Regulation Name

 

 

Eye sphere implant

 

 

Regulation No.

 

 

886.3320.

Identification An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Status 510(k)
Remarks  

NIL

 

 

 
 

 

 

 

 

 

 

 

 

 

HPZ

 

 

 

 

Device Name Implant, Eye Sphere
 

Class

 

2
 

Regulation Name

 

 

Eye sphere implant

 

 

Regulation No.

 

 

886.3320.

Identification An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Status 510(k)
Remarks  

NIL

 

 

 
 

 

 

 

 


MQU

 

 

 

 

 

 

Device Name Ocular Peg
 

Class

 

2
 

Regulation Name

 

 

Eye sphere implant

 

 

Regulation No.

 

 

886.3320.

Identification An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Status 510(k)
Remarks  

NIL

 

 
 

 

 

PUF

 

 

 

 

 

 

 

 

Device Name Ocular Peg, Exempt
 

Class

 

2
 

Regulation Name

 

 

Eye sphere implant

 

 

Regulation No.

 

 

886.3320.

 

Identification An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Status 510(k) exempt
Remarks  

Exemption is limited to ocular pegs supplied sterile.

 

This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

 

 
 

 

 

 

 

 

 

 

 

HQX

 

 

 

 

Device Name Implant, Orbital, Extra-Ocular
 

Class

 

2
 

Regulation Name

 

 

Extraocular orbital implant

 

Regulation No.

 

886.3340
Identification  

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

 

Status 510(k)
Remarks  

NIL

 

 

 
 

 

 

 

 

 

 

 

 

 

HQM

 

 

 

 

Device Name Keratoprosthesis, Permanent Implant
 

Class

 

2
 

Regulation Name

 

 

Keratoprosthesis

 

 

Regulation No.

 

886.3400
Identification  

A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.

 

Status 510(k)
Remarks  

NIL

 

 

 
 

 

 

 

 

 

 

 

 

MLP

 

 

 

 

Device Name Keratoprosthesis, Temporary Implant, Surgical Use
 

Class

 

2
 

Regulation Name

 

 

Keratoprosthesis

 

 

Regulation No.

 

886.3400
Identification  

A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.

 

Status 510(k)
Remarks  

NIL

 

 

 
 

 

 

 

 

 

 

HQT

 

 

 

 

 

Device Name Shell, Scleral
 

Class

 

2
 

Regulation Name

 

 

Scleral shell

 

 

Regulation No.

 

886.3800
Identification  

A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

 

Status 510(k) exempt
Remarks  

Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act).

 

 
 

 

 

 

 

 

 

KYF

 

 

 

 

 

Device Name Implant, Eye Valve
 

Class

 

2
 

Regulation Name

 

 

Aqueous shunt

 

Regulation No.

 

886.3920
Identification  

An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

 

Status 510(k)
Remarks  

NIL

 

 
LCC Device Name Applicator, Ocular Pressure
Class  

2

 

Regulation Name  

Ocular pressure applicator

 

 

Regulation No.

 

 

886.4610

 

 

Identification  

An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery

 

Status 510(K)
 

Remarks

 

 

NIL

 

 
OJK Device Name  

Eye Tray

 

Class  

2

 

 

Regulation Name  

Ophthalmic sponge

 

 

 

Regulation No.

 

 

886.4790

 

Identification  

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

 

Status  

510(K) Exempt

 

Remarks  

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

 

 
HOZ Device Name  

Sponge, Ophthalmic

 

Class  

2

 

Regulation Name  

Ophthalmic sponge

 

 

 

Regulation No.

 

 

886.4790

 

Identification  

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

 

Status  

510(K) Exempt

 

Remarks  

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

 

 
HRL Device Name  

Unit, Beta, Radiation, Ophthalmic

Class  

2

 

Regulation Name  

Ophthalmic beta radiation source

 

 

 

Regulation No.

 

 

886.5100

Identification  

An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

Status  

510(K)

 

Remarks NIL
 
MML Device Name  

Weights, Eyelid, External

 

Class  

2

 

Regulation Name  

Eyelid weight

 

 

 

Regulation No.

 

 

886.5700

Identification  

An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).

 

Status  

510(K)

 

Remarks  

NIL

 

MUW Device Name Lens, Contact (Orthokeratology)
Class  

2*

 

or

 

3#

 

Regulation Name  

 

Rigid gas permeable contact lens

 

 

 

 

Regulation No.

 

 

 

886.5916.

 

Identification  

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

 

Status  

510(K)

Remarks  

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

 

HQD Device Name Lens, Contact (Other Material) – Daily
Class  

2*

 

or

 

3#

 

Regulation Name  

 

Rigid gas permeable contact lens

 

 

Regulation No.

 

 

886.5916.

Identification  

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

 

Status  

510(K)

Remarks  

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

 

MRC Device Name Products, Contact Lens Care, Rigid Gas Permeable
Class  

2

 

Regulation Name  

 

Rigid gas permeable contact lens care products.

 

 

 

Regulation No.

 

 

 

886.5918

 

Identification  

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

 

Status 510(K)
Remarks  

NIL

 

MVN Device Name Lens, Contact, (Disposable)
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens.

 

 

Regulation No.

 

 

886.5925

Identification  

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

 

Status  

510(K)

 

Remarks  

NIL

 

NCZ Device Name Lens, Contact, (Disposable Lens, Contact, For Color Vision Deficiency)
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens.

 

 

 

Regulation No.

 

 

 

886.5925

 

Identification  

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

 

Status  

510(K)

 

Remarks  

NIL

 

NIZ Device Name Lens, Contact, For Reading Discomfort
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens.

 

 

Regulation No.

 

 

886.5925

 

Identification  

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

 

Status  

510(K)

 

Remarks  

NIL

 

LPL Device Name Lenses, Soft Contact, Daily Wear
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens.

 

 

 

Regulation No.

 

 

 

886.5925

 

Identification  

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

 

Status  

510(K)

 

Remarks  

NIL

 

LPL Device Name Lenses, Soft Contact, Daily Wear
Class  

2*

 

or

 

3#

 

Regulation Name  

Soft (hydrophilic) contact lens.

 

 

 

Regulation No.

 

 

 

886.5925

 

Identification  

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

 

Status  

510(K)

 

Remarks  

* Class II if the device is intended for daily wear only.

# Class III if the device is intended for extended wear.

 

LPN Device Name Accessories, Soft Lens Products
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens care products

 

 

 

Regulation No.

 

 

 

886.5928

 

Identification  

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Status  

510(K)

 

Remarks  

NIL

 

LYL Device Name Accessories, Solution, Ultrasonic Cleaners For Lenses
Class  

2

 

 

Regulation Name

 

 

Soft (hydrophilic) contact lens care products

 

Regulation No.

 

 

886.5928

 

Identification  

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

 

Status  

510(K)

 

Remarks  

NIL

 

LRX Device Name Case, Contact Lens
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens care products

 

 

 

Regulation No.

 

 

 

886.5928

Identification  

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

 

Status  

510(K)

 

Remarks  

NIL

 

LRX Device Name Case, Contact Lens
Class  

2

 

Regulation Name  

Soft (hydrophilic) contact lens care products

 

 

Regulation No.

 

 

886.5928

Identification  

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

 

Status  

510(K)

 

Remarks  

NIL