CANDELA MODEL MDL-1 LASER LITHOTRIPTOR

CANDELA MODEL MDL-1 LASER LITHOTRIPTOR is an FDA 510(k)-cleared medical device (K863642) manufactured by Candela Corp.. 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 December 2, 1986. Regulation: 8.