510(k) K260138 ยท GEX Powered Laser Surgical Instrument
LUNE PureHygiene
| Applicant | Enamel Pure, Worcester MA, US |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Jan 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260138
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.