VITLITE (TR7700)

VITLITE (TR7700) is an FDA 510(k)-cleared medical device (K963417) manufactured by Escalon Trek Medical. 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 December 19, 1996. Regulation: 8.