AIRO Suction Unit (AIRO-01)

AIRO Suction Unit (AIRO-01) is an FDA 510(k)-cleared medical device (K251101) manufactured by Cro, LLC. 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 April 25, 2025. Regulation: 8.