ClearanceBrief
510(k) K251435 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

InbellaIgnite RF System

ApplicantInbella Medical, Inc., Richmond Hill, CA
DecisionSubstantially Equivalent, Jan 27, 2026
ReceivedMay 8, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251435

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.