510(k) K250776 ยท GEX Powered Laser Surgical Instrument
Lithoblast Single Use Holmium Laser Fibers
| Applicant | Dawell Medical, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Oct 14, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250776
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.