LUMENIS SELECTA DUET

LUMENIS SELECTA DUET is an FDA 510(k)-cleared medical device (K021550) manufactured by Ellex Medical Pty, 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 August 8, 2002. Regulation: 8.