510(k) K250998 · GEX Powered Laser Surgical Instrument
CO2 Laser Therapy System (Model: LFS-D9U)
| Applicant | Sanhe Lefis Electronics Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Apr 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250998
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.