510(k) K253007 ยท GEX Powered Laser Surgical Instrument
Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
| Applicant | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253007
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.