510(k) K261817 ยท GEX Powered Laser Surgical Instrument
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
| Applicant | Zhengzhou PZ Laser Slim Technology Co., Ltd., Zhengzhou, CN |
| Decision | Substantially Equivalent, Sep 17, 2026 |
| Received | Jun 1, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261817
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.