510(k) K170409 ยท GEX Powered Laser Surgical Instrument
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
| Applicant | Topcon Medical Laser Systems, Inc. (Tmls), Livermore CA, US |
| Decision | Substantially Equivalent, Sep 12, 2017 |
| Received | Feb 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170409
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.