510(k) K261589 ยท GEX Powered Laser Surgical Instrument
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
| Applicant | Zhengzhou PZ Laser Slim Technology Co., Ltd., Zhengzhou, CN |
| Decision | Substantially Equivalent, Sep 2, 2026 |
| Received | May 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261589
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.