510(k) K191079

Piezon Built-in Kit, Piezon Built-in Kit LED by E.M.S Electro Medical Systems S.A — Product Code ELC

K191079 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "Piezon Built-in Kit, Piezon Built-in Kit LED". The FDA issued a decision of Substantially Equivalent on August 16, 2019. 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.