510(k) K252063 ยท GEX Powered Laser Surgical Instrument
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
| Applicant | Wuhan Dimed Laser Technology Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jul 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252063
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.