FDA-cleared AI ophthalmic devices
The FDA's AI-enabled device list has 10 devices whose lead review panel is Ophthalmic, 0.6% of all 1,614 listed devices. They come from 9 companies. The first decision was on April 11, 2018 and the most recent on April 17, 2025.
10AI devices
6Companies
2018First decision
2025-04-17Latest decision
Trend: devices per year
20182019202020212022202320242025
Top companies
Most common product codes
All 10 devices, newest first
- CLARUS (700)Carl Zeiss Meditec, Inc. · Ophthalmic
- Notal Vision Home Optical Coherence Tomography (OCT) SystemNotal Vision Inc · Ophthalmic
- AEYE-DSAEYE Health Inc. · Ophthalmic
- EyeArt v2.2.0Eyenuk, Inc. · Ophthalmic
- AEYE-DSAEYE Health, Inc. · Ophthalmic
- IDx-DR v2.3Digital Diagnostics Inc. · Ophthalmic
- IDx-DRDigital Diagnostics Inc. · Ophthalmic
- EyeArtEyenuk, Inc · Ophthalmic
- CLARUSCarl Zeiss Meditec, Inc · Ophthalmic
- IDx-DRIDx, LLC · Ophthalmic
Frequently asked questions
How many FDA-cleared AI ophthalmic devices are there?
As of the FDA list updated through June 29, 2026, 10 AI-enabled devices have Ophthalmic as their lead review panel (0.6% of the list).
Which companies have the most AI ophthalmic devices?
Digital Diagnostics Inc. (2), Carl Zeiss Meditec, Inc. (1), Notal Vision Inc (1) have the most AI-enabled ophthalmic devices on the FDA list.
Which year had the most AI ophthalmic authorizations?
2022 had the most, with 2 devices.
Which FDA pathways are used for AI ophthalmic devices?
510(k): 8; De Novo: 2.
What was the most recent AI ophthalmic device on the list?
CLARUS (700) from Carl Zeiss Meditec, Inc. (K243878), with a decision dated April 17, 2025.