FDA 510(k) Ophthalmic Devices
About Ophthalmic Devices
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
FDA 510(k) Cleared Ophthalmic Devices
This page lists all 41 medical devices in the Ophthalmic specialty that have been submitted to the FDA through the 510(k) premarket notification process. Contact lenses, IOLs, ophthalmic lasers and retinal imaging systems.
- 40 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 133 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 41 medical devices in the Ophthalmic specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 40 were cleared as substantially equivalent to a predicate device. Average FDA review time: 133 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to ophthalmic
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices