| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2025-04-17 | K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | Ophthalmic |
| 2024-05-15 | DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision Inc | Ophthalmic |
| 2024-04-23 | K240058 | AEYE-DS | AEYE Health Inc. | Ophthalmic |
| 2023-06-16 | K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | Ophthalmic |
| 2022-11-10 | K221183 | AEYE-DS | AEYE Health, Inc. | Ophthalmic |
| 2022-06-17 | K213037 | IDx-DR v2.3 | Digital Diagnostics Inc. | Ophthalmic |
| 2021-06-10 | K203629 | IDx-DR | Digital Diagnostics Inc. | Ophthalmic |
| 2020-08-03 | K200667 | EyeArt | Eyenuk, Inc | Ophthalmic |
| 2019-06-25 | K191194 | CLARUS | Carl Zeiss Meditec, Inc | Ophthalmic |
| 2018-04-11 | DEN180001 | IDx-DR | IDx, LLC | Ophthalmic |