510(k) K191162 ยท GEX Powered Laser Surgical Instrument
EpiLaze Multi-wavelength Laser
| Applicant | Rohrer Aesthetics, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Jul 9, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191162
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.