FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 169d |
| All-time average (cleared) | 110d |
| Not Substantially Equivalent (denied) | 403d |
Recent Ophthalmic submissions have taken longer than the historical average - 169 days in the last 2 years vs 110 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 403 days before receiving a Not Substantially Equivalent determination.
This page lists all 5119 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.
This page lists 5119 medical devices in the Ophthalmic specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 5101 were cleared as substantially equivalent to a predicate device. Average FDA review time: 110 days. Records from 1976 to the present.
You can use this list to:
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.
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