510(k) K260489 ยท GEX Powered Laser Surgical Instrument
LASEmaR 1500
| Applicant | Eufoton S.R.L., Trieste, IT |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Feb 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260489
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.