510(k) K251464 ยท GEX Powered Laser Surgical Instrument
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
| Applicant | Jeisys Medical Incorporated, Seoul, KR |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | May 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251464
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.