CLL- V1 LIGHT SOURCE

CLL- V1 LIGHT SOURCE is an FDA 510(k)-cleared medical device (K130819) manufactured by Olympus Winter & Ibe GmbH. 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 June 18, 2013. Regulation: 8.