510(k) K252447 ยท GEX Powered Laser Surgical Instrument
Picosecond laser device (BMPS4)
| Applicant | Hebei Newangie Technology Co., Ltd., Shijiazhuang City, CN |
| Decision | Substantially Equivalent, Oct 1, 2025 |
| Received | Aug 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252447
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.