ClearanceBrief
510(k) K251049 ยท GEX Powered Laser Surgical Instrument

SurgiLight 1470 Diode Laser System (Model:Halo)

ApplicantMicro-Energy Medical Technology Co., Ltd., Shenzhen, CN
DecisionSubstantially Equivalent, Jul 2, 2025
ReceivedApr 3, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251049

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.