510(k) K250195 ยท GEX Powered Laser Surgical Instrument
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
| Applicant | Matelaser, Inc., Miami FL, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Jan 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250195
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.