510(k) K252745 ยท GEX Powered Laser Surgical Instrument
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
| Applicant | Micro-Energy Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Aug 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252745
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.