ZARA ZONE IV MALAR IMPLANT

ZARA ZONE IV MALAR IMPLANT is an FDA 510(k)-cleared medical device (K914016) manufactured by Byron Medical. 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 December 4, 1991. Regulation: 8.