PHOTOTHERAPEUTIX MODEL 1650B

PHOTOTHERAPEUTIX MODEL 1650B is an FDA 510(k)-cleared medical device (K933953) manufactured by Avex Industries , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 1995. Regulation: 8.