510(k) K210701 ยท OOE Ophthalmic Femtosecond Laser
CATALYS Precision Laser System
| Applicant | Amo Manufacturing USA, LLC, Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 7, 2021 |
| Received | Mar 9, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210701
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.