AART MALAR IMPLANT

AART MALAR IMPLANT is an FDA 510(k)-cleared medical device (K021419) manufactured by Aesthetic and Reconstructive Technologies, Inc.. 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 July 1, 2002. Regulation: 8.