Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems is an FDA 510(k)-cleared medical device (K220877) manufactured by Lumenis Be, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2022. Regulation: 8.