510(k) K172002 ยท OOE Ophthalmic Femtosecond Laser
Catalys Precision Laser System
| Applicant | Amo Manufacturing USA, LLC, Milpitas CA, US |
| Decision | Substantially Equivalent, Aug 25, 2017 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2018 | Johnson & Johnson Surgical Vision Inc OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33
Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMe Terminated |
OOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.