510(k) K252319 · GEX Powered Laser Surgical Instrument
Q-Switched Nd: YAG Laser machine (LFS-C13U)
| Applicant | Sanhe Lefis Electronics Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Oct 20, 2025 |
| Received | Jul 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252319
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.