510(k) K243279

DOLORCLAST Focused Shock Waves by E.M.S Electro Medical Systems S.A — Product Code PZL

K243279 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "DOLORCLAST Focused Shock Waves". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers), a Class II device regulated under 21 CFR 878.4685. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.