WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 is an FDA 510(k)-cleared medical device (K963227) manufactured by Products For Medicine. 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 October 22, 1996. Regulation: 8.