XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII is an FDA 510(k)-cleared medical device (K062895) manufactured by Dutch Ophthalmic Research Center International BV. 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 12, 2006. Regulation: 8.