510(k) K191685 ยท GEX Powered Laser Surgical Instrument
PicoWay Laser System
| Applicant | Candela Corporation, Wayland MA, US |
| Decision | Substantially Equivalent, Sep 16, 2019 |
| Received | Jun 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191685
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.