510(k) K182083 ยท OOE Ophthalmic Femtosecond Laser
Catalys Precision Laser System
| Applicant | Amo Manufacturing USA, LLC, Milpitas CA, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Aug 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182083
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.