510(k) K260632 ยท GEX Powered Laser Surgical Instrument
LASER THERMAL THERAPY KIT
| Applicant | Elesta S.P.A, Calenzano, IT |
| Decision | Substantially Equivalent, Mar 17, 2026 |
| Received | Feb 26, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260632
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.