SONOLITH I-MOVE

SONOLITH I-MOVE is an FDA 510(k)-cleared medical device (K111808) manufactured by Edap Tms France. 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 31, 2011. Regulation: 8.