510(k) K234004 ยท GEX Powered Laser Surgical Instrument
Medical diode laser systems (CHARISMA, REGAL)
| Applicant | Reveal Lasers , Ltd., Aviv, IL |
| Decision | Substantially Equivalent, Feb 20, 2025 |
| Received | Dec 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234004
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.