510(k) K251303 ยท GEX Powered Laser Surgical Instrument
Tamburo Thulium Fiber Laser System
| Applicant | Menovex Medical Technology (Shenzhen) Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Nov 4, 2025 |
| Received | Apr 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251303
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.