510(k) K203799 ยท GEX Powered Laser Surgical Instrument
ProFlex CO2 Laser Fiber
| Applicant | Innovaquartz, LLC, Phoenix AZ, US |
| Decision | Substantially Equivalent, Sep 20, 2021 |
| Received | Dec 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203799
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.