SURGIMAX/ SURGIMAX PLUS

SURGIMAX/ SURGIMAX PLUS is an FDA 510(k)-cleared medical device (K100390) manufactured by Elliquence, LLC. 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 24, 2010. Regulation: 8.