510(k) K190007 ยท GEX Powered Laser Surgical Instrument
Vydence Laser Family
| Applicant | Vydence Medical Industria E Comercio Ltda, Ceat - Sao Carlos, BR |
| Decision | Substantially Equivalent, Mar 1, 2019 |
| Received | Jan 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190007
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.