STARLITE-OM, LIGHT EFFECTS, THIBIANT

STARLITE-OM, LIGHT EFFECTS, THIBIANT is an FDA 510(k)-cleared medical device (K133546) manufactured by Ps Advanced Engineering. 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 August 5, 2014. Regulation: 8.