510(k) K210847 ยท GEX Powered Laser Surgical Instrument
UltraClear Fractional Laser System
| Applicant | Fa International, LP, Lincoln RI, US |
| Decision | Substantially Equivalent, Dec 10, 2021 |
| Received | Mar 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210847
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.