510(k) K252427 ยท GEX Powered Laser Surgical Instrument
Diode Laser Hair Removal Machine (GLD01)
| Applicant | Sanhe Meditech Co., Ltd., Sanhe, CN |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Aug 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252427
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.