EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)

EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) is an FDA 510(k)-cleared medical device (K012445) manufactured by Electro Medical Systems SA. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2001. Regulation: 8.