510(k) K261701 ยท GEX Powered Laser Surgical Instrument
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
| Applicant | Micro-Energy Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | May 22, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261701
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.