510(k) K230893

Swiss LthoClast Trilogy by E.M.S Electro Medical Systems S.A — Product Code FEO

K230893 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "Swiss LthoClast Trilogy". The FDA issued a decision of Substantially Equivalent on October 23, 2023. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.