510(k) K213761 ยท GEX Powered Laser Surgical Instrument
Joule diVa System
| Applicant | Sciton, Inc, Palo Alto CA, US |
| Decision | Substantially Equivalent, Jul 19, 2022 |
| Received | Dec 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213761
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.