510(k) K251801 ยท GEX Powered Laser Surgical Instrument
Diode laser device (BM091)
| Applicant | Hebei Newangie Technology Co., Ltd., Shijiazhuang, CN |
| Decision | Substantially Equivalent, Aug 8, 2025 |
| Received | Jun 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251801
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.