ClearanceBrief
510(k) K251919 ยท GEX Powered Laser Surgical Instrument

Thulium Laser System (Deluxlase)

ApplicantNanjing Bestview Laser S&T Co., Ltd., Nanjing, CN
DecisionSubstantially Equivalent, Sep 26, 2025
ReceivedJun 23, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251919

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.