510(k) K253951 ยท GEX Powered Laser Surgical Instrument
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
| Applicant | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Mar 6, 2026 |
| Received | Dec 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253951
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.