ClearanceBrief
510(k) K250809 ยท GEX Powered Laser Surgical Instrument

Stellar M22

ApplicantLumenis Be, Ltd., Yokneam, IL
DecisionSubstantially Equivalent, Apr 16, 2025
ReceivedMar 17, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250809

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.