510(k) K252519 ยท GEX Powered Laser Surgical Instrument
CO2 Laser Therapy System (K106)
| Applicant | Hebei Keylaser Sci-Tech Co.,Ltd, Baoding, CN |
| Decision | Substantially Equivalent, Nov 7, 2025 |
| Received | Aug 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252519
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.