510(k) K252345 ยท GEX Powered Laser Surgical Instrument
Picosecond Laser Device (PF131-BI)
| Applicant | Risu Medical Technology Co., Ltd., Fengxi New City Of Xixian New Area, CN |
| Decision | Substantially Equivalent, Oct 23, 2025 |
| Received | Jul 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252345
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.