FDA 510(k) Ophthalmic Devices

FDA 510(k) Ophthalmic Devices - Regulatory Overview

FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.

Main categories:

• Contact lenses - daily, extended wear, toric and multifocal lenses
• Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
• Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
• Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
• Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps