FDA 510K for Surgical Lamp

Surgical lamps are medical devices intended to provide clear, consistent illumination of the patient’s body during surgeries, diagnostic procedures, and medical treatments.

As visibility directly impacts clinical performance and patient safety, these lights must meet strict technical and quality requirements to ensure reliable brightness, accurate color rendering, and shadow control throughout the procedure.

In simple terms, it is an operating-room light used to clearly illuminate the area where surgery is being performed.

Intended Use of Surgical Lamp

A surgical lamp (including its fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Lamp, Operating-Room*

Intended use: The operating-room lamp is intended to provide visible illumination of the surgical or procedural field and patient to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It consists of one or more high-intensity visible light sources, optical reflectors and lenses, mounting and positioning mechanisms, and user controls to deliver bright, focused illumination to the operative or procedural field. The system is designed specifically for use in operating rooms and similar clinical environments to improve clinician visualization of tissues and anatomy. The device does not perform diagnostic or therapeutic functions, and its sole function is to provide visible light illumination.

Light, Surgical, Instrument*

Intended use: The surgical light accessory is intended to provide visible illumination of the surgical or procedural field and patient by modifying, adapting, or directing light from a primary surgical lighting system to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It is designed to function with one or more primary surgical lighting systems to modify, direct, or adapt visible illumination to targeted areas of the surgical or procedural field. The accessory may include optical components such as reflectors, lenses, adapters, and mechanical structures used to direct, split, or condition light output from a primary surgical lamp. The device does not itself emit light, perform diagnostic functions, or provide treatment; its function is solely to enhance the delivery or control of visible light to support clinician visualization during clinical procedures.

Light, Surgical, Floor Standing*

Intended use: The surgical lighting accessory is intended to provide visible illumination of the surgical or procedural field and patient by distributing or modifying light from a primary surgical lamp to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It is designed to work with a primary surgical lighting system to distribute, redirect, or augment visible light to targeted areas of the surgical or procedural field. The accessory includes optical and/or mechanical components (such as reflectors, diffusers, adapters, or mounting fixtures) that modify the light output of a primary surgical lamp. The device does not itself generate light, diagnose, or treat any condition; its function is solely to enhance delivery of visible illumination in support of clinician visualization during clinical procedures.

Light, Surgical, Fiberoptic

Intended use: The surgical illumination device is intended to provide visible illumination of the surgical or procedural field, patient, and associated operative areas to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It consists of one or more high-intensity visible light sources, optical reflectors and lenses, mounting and positioning mechanisms, and user controls for light intensity and positioning. The system produces bright, focused visible illumination targeted to the operative or procedural field to improve visualization of tissues and anatomical structures. The device does not perform diagnostic or therapeutic functions; its function is solely to provide surgical illumination.

Light, Surgical, Endoscopic*

Intended use: Endoscopic Surgical Light is intended to provide visible illumination of the surgical or procedural field, including endoscopic operative sites, to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It consists of a light source and optical delivery components designed to provide bright, focused visible illumination specifically for endoscopic or minimally invasive procedures. The system may include light cables, fiberoptic or LED light guides, and connectors that transmit visible light to an endoscopic instrument or operative field. The device does not perform diagnosis or therapy; its function is solely to deliver visible light to improve clinician visualization of anatomical structures during clinical procedures.

Light, Surgical, Connector*

Intended use: The beam splitting surgical light accessory is intended to provide visible illumination to the surgical or procedural field and/or patient by splitting or redirecting light from a primary surgical lamp to enhance visualization of anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It is designed to accept light from a primary surgical lighting source and split, redirect, or distribute the light to additional areas of the surgical or procedural field. The accessory typically includes optical beam-splitting elements and mechanical components for attachment and positioning. The device does not itself emit light, diagnose, or treat any condition; its function is solely to assist in delivering visible illumination by modifying the light output of a primary surgical lamp.

Light, Surgical, Ceiling Mounted*

Intended use: The ceiling-mounted surgical light is intended to provide visible illumination of the surgical or procedural field and patient to assist healthcare professionals in visualizing anatomical structures during surgical, diagnostic, and medical procedures.

Device Description: It consists of one or more ceiling-mounted light heads incorporating a high-intensity visible light source (such as LED or equivalent), optical reflectors and lenses, mounting structure, and user controls for beam positioning and intensity adjustment. The system is designed to deliver bright, focused visible light to the operative or procedural field to improve clinician visualization of tissues and anatomy. The device does not perform diagnostic or therapeutic functions and is intended solely for surgical illumination.

Light, Surgical, Carrier*

Intended use: The surgical light carrier is intended to support and position a surgical lighting fixture to provide visible illumination of the surgical or procedural field or patient during surgical and medical procedures.

Device Description: It consists of a structural carrier assembly (e.g., ceiling or wall-mounted support arm/frame) designed to hold, position, and stabilize one or more surgical light heads. The carrier includes mounting interfaces and adjustable joints or locking mechanisms that allow controlled positioning of the light fixture during use. The device does not emit light and does not perform diagnostic or therapeutic functions; its role is to mechanically support and orient the surgical lighting system.

Light, Surgical, Accessories*

Intended use: It is intended to provide auxiliary visible illumination of the surgical or procedural field to support clinician’s visualization during surgical and medical procedures.

Device Description: It consists of a medical-grade light head assembly with an integrated visible light source and optical components (e.g., reflector/lens) designed to deliver bright, focused illumination to the surgical or procedural field. The device may be mounted or positioned using a compatible support system and includes user controls for light activation and intensity adjustment, as applicable. The device provides illumination only and does not perform diagnostic or therapeutic functions.

Lamp, Surgical*

Intended use: The surgical lamp is intended to provide visible illumination of the surgical field or patient during surgical and procedural interventions to assist healthcare professionals in the visualization of anatomical structures.

Device Description: The surgical lamp is a medical lighting device that produces visible illumination for use in surgical or procedural settings. Typical features include:

• A high-intensity visible light source (e.g., LED, halogen),
• Optical reflectors and lenses to shape, focus, and direct the light beam,
• A mounting/positioning system (ceiling, wall, or mobile arm),
• Controls for adjusting light intensity and direction.

The device’s purpose is exclusively to provide bright, focused light to improve visualization of the operative field. It does not perform any diagnostic or therapeutic functions.

Illuminator, Non-Remote

Intended use: The non-remote illuminator is intended to provide focused visible illumination directly at the surgical or procedural field, with the light source located within or integrated into the illuminator head, to support clinician visualization during procedures.

Device Description: It is a non-remote Illuminator designed to deliver bright, focused visible light directly to the surgical or procedural field. Typical components include:

• A light source (such as an incandescent lamp, LED, or equivalent),
• Optical reflectors and lenses to shape and direct the beam,
• A housing and mounting or positioning assembly,
• User controls for intensity adjustment and beam positioning.

The device produces cool, high-quality visible illumination to improve visualization of anatomical structures during clinical procedures. It does not perform any diagnostic or therapeutic function; its purpose is solely to support clinician visualization by providing adequate illumination to the operative area.

Illuminator, Remote*

Intended use: The remote illuminator is intended to provide visible illumination of the surgical or procedural field using a remotely located light source with light delivered to the field through an optical transmission pathway, to support clinician visualization during procedures.

Device Description: It is a medical lighting device that supplies remote or auxiliary visible illumination to surgical or procedural fields. Typical components include:

• A light source (e.g., tungsten halogen, LED, or equivalent),
• Optical elements (reflectors, lenses, filters) for beam shaping,
• Connector(s) or mounts for positioning the illuminator relative to the surgical field,
• Controls for adjusting light intensity and focus.

The device is designed to produce cool, bright visible light without causing undue heat at the point of illumination. It augments the primary surgical lighting system to improve visualization of tissues and procedural details. The product does not perform diagnostic or therapeutic functions; its function is solely illumination

Lamp, Surgical, Incandescent

Intended use: The incandescent surgical lamp is intended to provide visible illumination of the surgical or procedural field using an incandescent light source to assist healthcare professionals during surgical and clinical procedures.

Device Description: It consists of an incandescent light source housed in a lamp assembly designed to deliver bright, focused visible illumination to a surgical or procedural field. Typical components include a light bulb(s), reflectors and lenses to shape and direct the beam, a mounting or positioning system (e.g., ceiling, wall, or portable stand), and user controls for adjusting intensity and direction. The device does not perform diagnostic or therapeutic functions; its sole function is to provide high-quality illumination to support clinical tasks.

Illuminator, Fiberoptic, Surgical Field

Intended use: The fiberoptic surgical field illuminator is intended to provide visible illumination of the surgical field by transmitting light through a fiberoptic cable to improve visualization of tissues and anatomical structures during surgical procedures.

Device Description: It is an illuminator, a fiberoptic, surgical field device, medical lighting system that provides fiberoptic-delivered visible illumination for clinical and surgical environments. Typical components include:

• A light source (e.g., high-intensity lamp or LED),
• Fiberoptic cables that transmit light,
• A light head that directs illumination onto the surgical or procedural field,
• Mounting or positioning mechanisms and controls light intensity and focus.

The device produces cool, bright visible light via fiberoptic transmission to improve visualization of the surgical field without adding thermal load to tissues. It does not perform diagnostic or therapeutic functions; its primary role is illumination to support clinician tasks.

Lamp, Fluorescein, Ac-Powered

Intended use: It is intended to provide visible illumination for examination and clinical procedures. It is an AC-powered examination and procedural light system used to illuminate patients and procedural fields in medical settings, assisting healthcare professionals in visualizing anatomy during examination or treatment.

Device Description: It is an AC-powered medical examination lighting system designed to deliver adjustable, cool, color-corrected visible illumination for clinical examination, treatment, and procedural areas. It consists of a light head with one or more lamps, optical reflectors/filters, adjustable mounting (e.g., ceiling, wall, or mobile stand), and controls for intensity and focus. The system produces a concentrated beam of visible light with nominal intensity suitable for clinical use, enhancing visualization of patient anatomy and procedural details.

Light-Based Imaging

Intended use: It is intended for Emission and collection of light to create an image for medical purposes.

Device Description: It is a device that is a light source in a housing and light detectors in a housing that can be aimed at a target tissue. It emits light that is collected from the target tissue and then analyzed to provide information about the target

Multi-Photon Imaging

Intended use: Provide visible illumination in a surgical or procedural setting to illuminate the operative field or patient.

Device Description: The Multi-Photon Imaging System is a non-implantable, light-based medical imaging device used to capture high-resolution images of in-vivo tissue microstructures for clinician review. The system includes a laser/light source, optical scanning and focusing components, detectors, and image processing software with a display interface. The device works by delivering controlled light energy into tissue and detecting returned optical signals generated through reflectance and multi-photon excitation, which are processed into digital images for visualization and interpretation.

Performance Testing (Analytical) for Surgical Lamp

• Illuminance (lux) output at specified distance
• Light field diameter & adjustability
• Uniformity of illumination across field
• Depth of illumination
• Shadow dilution / obstruction performance
• Color temperature (Kelvin)
• Color rendering index (CRI)
• Light intensity control accuracy (dimming range)
• Heat rise at surgical field / patient area
• Light head stability (drift, sag, positioning hold)
• EMC and Electrical Safety-IEC 60601
• Software verification and Validation

Clinical Testing:

No Guidance available for 510k submission