510(k) K260375 ยท GEX Powered Laser Surgical Instrument
Nd: YAG Laser Therapy Systems
| Applicant | Sanhe Meditech Co., Ltd., Sanhe, CN |
| Decision | Substantially Equivalent, Mar 31, 2026 |
| Received | Feb 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260375
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.