510(k) K233344 ยท GEX Powered Laser Surgical Instrument
Regenalase Laser System
| Applicant | Ipg Medical, Marlborough MA, US |
| Decision | Substantially Equivalent, May 28, 2024 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233344
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.