510(k) K252658 ยท GEX Powered Laser Surgical Instrument
Medical Diode Laser Systems (TR-B)
| Applicant | Baoding Te'Anzhou Electronic Technology Co., Ltd., Baoding, CN |
| Decision | Substantially Equivalent, Nov 28, 2025 |
| Received | Aug 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252658
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.