510(k) K253828 ยท GEX Powered Laser Surgical Instrument
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
| Applicant | Beijing HuaCheng Taike Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Feb 27, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253828
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.