510(k) K142638 ยท GEX Powered Laser Surgical Instrument
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
| Applicant | Innovaquartz, LLC, Phoenix AZ, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Sep 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142638
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.