510(k) K261964 ยท GEX Powered Laser Surgical Instrument
ECHOLASER X4
| Applicant | Elesta S.P.A, Calenzano, IT |
| Decision | Substantially Equivalent, Aug 19, 2026 |
| Received | Jun 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261964
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.