510(k) K261047 ยท GEX Powered Laser Surgical Instrument
Dental Diode Laser Device (Laser-Pen)
| Applicant | Guilin Kevin Peter Technology Co., Ltd., Guilin, CN |
| Decision | Substantially Equivalent, Sep 18, 2026 |
| Received | Mar 31, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261047
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.