510(k) K121091 ยท OOE Ophthalmic Femtosecond Laser
CATALYS PRECISION LASER SYSTEM
| Applicant | Optimedica Corporation, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 28, 2012 |
| Received | Apr 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121091
| 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 |
| Jan 8, 2014 | Optimedica Corporation Catalys Precision Laser System (United States) - Catalys-U:
Catalys Precision Laser System (International) - Catalys I
200-240V ~, 50/60 Hz, 15A,
(2) 15A Resettable CB:
Tested and complies with FCC P Terminated |
OOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.