510(k) K252787 ยท GEX Powered Laser Surgical Instrument
Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
| Applicant | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Nov 24, 2025 |
| Received | Sep 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252787
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.