510(k) K253633 ยท GEX Powered Laser Surgical Instrument
Holmium Laser Therapeutic Apparatus (HZ-40)
| Applicant | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jan 24, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253633
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.