LO-50 LED LIGHT SOURCE

LO-50 LED LIGHT SOURCE is an FDA 510(k)-cleared medical device (K102167) manufactured by Fiberoptics Technology, Inc.. 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 16, 2010. Regulation: 8.