ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2

ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 is an FDA 510(k)-cleared medical device (K121724) manufactured by Richard Wolf Medical Instruments 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 September 19, 2012. Regulation: 8.