510(k) K113479 ยท OOE Ophthalmic Femtosecond Laser
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
| Applicant | Optimedica Corporation, Santa Clara CA, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Nov 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2021 | AMO Manufacturing USA, LLC Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 Open, Classified |
OOE | None listed |
| 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.