CLARUS (700) is an AI-enabled medical device from Carl Zeiss Meditec, Inc., listed by FDA (510(k), K243878) with a decision date of 2025-04-17. Review panel: Ophthalmic.
| FDA submission number | K243878 |
|---|---|
| Pathway | 510(k) |
| Company | Carl Zeiss Meditec, Inc. |
| Review panel (specialty) | Ophthalmic |
| FDA decision date | 2025-04-17 |
| Decision | Substantially Equivalent |
| Product code | QER |
| Classification | Camera, Ophthalmic, Slit-Scanning |
| Device class | 2 |
| Regulation number | 886.1120 |
| Review time (calendar days) | 120 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Ophthalmic AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.