510(k) K253254

GBT Machine Airflow Prophylaxis Master by E.M.S Electro Medical Systems S.A — Product Code ELC

K253254 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "GBT Machine Airflow Prophylaxis Master". The FDA issued a decision of Substantially Equivalent on January 28, 2026. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.