OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM

OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM is an FDA 510(k)-cleared medical device (K040270) manufactured by Lumenis, Ltd.. 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 15, 2004. Regulation: 8.