510(k) K192617 ยท GEX Powered Laser Surgical Instrument
Gemini 810+980 Soft Tissue Laser
| Applicant | Azena Medical, LLC, Walnut Creek CA, US |
| Decision | Substantially Equivalent, Feb 20, 2020 |
| Received | Sep 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192617
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.