510(k) K243630 ยท GEX Powered Laser Surgical Instrument
Medical Laser System Incanto / Evoline Platinum /Evoline
| Applicant | Solar LS Cjsc, Minsk, BY |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Nov 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243630
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.