ClearanceBrief
510(k) K252723 ยท GEX Powered Laser Surgical Instrument

Dynamis Pro Family

ApplicantFotona D.O.O., Ljubljana, SI
DecisionSubstantially Equivalent, Sep 19, 2026
ReceivedAug 28, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252723

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.