510(k) K261562 · GEX Powered Laser Surgical Instrument
Diode Laser Therapy System
| Applicant | Sanhe LEFIS Electronics Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | May 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261562
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.