SONOLITH I-SYS LITHOTRIPER

SONOLITH I-SYS LITHOTRIPER is an FDA 510(k)-cleared medical device (K083614) manufactured by Technomed 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 July 26, 2009. Regulation: 8.