ClearanceBrief
510(k) K261094 ยท GEX Powered Laser Surgical Instrument

YellowStar

ApplicantAsclepion Laser Technologies GmbH, Jena, DE
DecisionSubstantially Equivalent, Apr 29, 2026
ReceivedApr 2, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K261094

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.