510(k) Ophthalmic Devices

FDA 510(k) Cleared Ophthalmic Devices

This page lists all 5085 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.

• 5067 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 109 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.