Phaco Emulsification Device
Cataract surgery is a procedure to remove natural but damaged cloudy lens or cataract from the eye to improve vision. To successfully conduct the Phacoemulsification surgery generally an ultrasonic device is used.
Intended use: The device is used to emulsify the cataract by ultrasonic vibrations of a phaco tip or needle that is inserted into the anterior chamber of the eye. Through irrigation of BSS and aspiration of emulsified lens pieces in a fluidic circuit , the devices removes the cataract progressively. The surgery duration will come under transient classification of less than 60 minutes. The product also integrates a vitrectomy cutter and a diathermy probe for coagulation to halt bleeding.
I need to be sure about the MDR classification but in all probability, it may be coming under class IIb as applicable to ‘surgical ultrasound devices. Please give a justifiable answer.