ClearanceBrief
510(k) K253254 ยท ELC Scaler, Ultrasonic

GBT Machine Airflow Prophylaxis Master

ApplicantE.M.S Electro Medical Systems S.A, Nyon, CH
DecisionSubstantially Equivalent, Jan 28, 2026
ReceivedSep 29, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253254

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.