ClearanceBrief
510(k) K262877 · GEX Powered Laser Surgical Instrument

SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

ApplicantOlympus Surgical Technologies America, Westborough MA, US
DecisionSubstantially Equivalent, Sep 16, 2026
ReceivedAug 17, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K262877

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.