510(k) K180140 ยท GEX Powered Laser Surgical Instrument
ProFlex Laser Fibers
| Applicant | Innovaquartz, LLC, Phoenix AZ, US |
| Decision | Substantially Equivalent, Apr 20, 2018 |
| Received | Jan 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180140
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.