510(k) K234085 · GEX Powered Laser Surgical Instrument
LUNE PureHygiene
| Applicant | Enamel Pure, Worcester MA, US |
| Decision | Substantially Equivalent, Mar 25, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234085
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.