
Alma Lasers, Inc.
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The Alma Opus System, Colibri Applicator and Tips is an FDA 510(k)-cleared medical device (K201520) manufactured by Alma Lasers, 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 October 26, 2021. Regulation: 8.