510(k) K141079 ยท OOE Ophthalmic Femtosecond Laser
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
| Applicant | Optimedica Corporation, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 11, 2014 |
| Received | Apr 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141079
| 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 |
| May 28, 2015 | Optimedica Corporation Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05
The OptiMedica Catalys Precision Laser System is indicated for use in patients und Terminated |
OOE | None listed |
| Apr 23, 2015 | Abbott Medical Optics, Inc. OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US).
Product Usage:
Indicated for use in patients undergoing cataract surgery for removal of crystallin Terminated |
OOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.