ClearanceBrief
510(k) K251329 ยท GEX Powered Laser Surgical Instrument

Diode laser device (RF3120-BI)

ApplicantRisu Medical Technology Co., Ltd., Fengxi New City Of Xixian New Area, CN
DecisionSubstantially Equivalent, Jun 27, 2025
ReceivedApr 30, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251329

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.