INDIGO OPTIMA LASER SYSTEM

INDIGO OPTIMA LASER SYSTEM is an FDA 510(k)-cleared medical device (K013493) manufactured by Ethicon Endo-Surgery, 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 December 12, 2001. Regulation: 8.