CLARUS is an AI-enabled medical device from Carl Zeiss Meditec, Inc, listed by FDA (510(k), K191194) with a decision date of 2019-06-25. Review panel: Ophthalmic.
| FDA submission number | K191194 |
|---|---|
| Pathway | 510(k) |
| Company | Carl Zeiss Meditec, Inc |
| Review panel (specialty) | Ophthalmic |
| FDA decision date | 2019-06-25 |
| Decision | Substantially Equivalent |
| Product code | QER |
| Classification | Camera, Ophthalmic, Slit-Scanning |
| Device class | 2 |
| Regulation number | 886.1120 |
| Review time (calendar days) | 53 |
| 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.