510(k) K260257 ยท GEX Powered Laser Surgical Instrument
CO2 Laser System
| Applicant | Sanhe Meditech Co., Ltd., Sanhe, CN |
| Decision | Substantially Equivalent, Mar 28, 2026 |
| Received | Jan 28, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260257
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.