ClearanceBrief
510(k) K243683 ยท GEX Powered Laser Surgical Instrument

Deka Bluebeam

ApplicantEl.En S.P.A., Calenzano, IT
DecisionSubstantially Equivalent, Jun 12, 2025
ReceivedNov 29, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243683

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.