510(k) K220041 ยท GEX Powered Laser Surgical Instrument
HandPICO
| Applicant | Vydence Medical Industria E Comercio Ltda, Ceat - Sao Carlos/Sp Sao Paulo, BR |
| Decision | Substantially Equivalent, May 5, 2022 |
| Received | Jan 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220041
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.