510(k) K261572 ยท GEX Powered Laser Surgical Instrument
Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
| Applicant | Keyue (Hangzhou) Medical Information Technology Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Oct 13, 2026 |
| Received | May 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261572
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.