
Aerin Medical, Inc.
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InSeca ARC Stylus, Aerin Console is an FDA 510(k)-cleared medical device (K162810) manufactured by Aerin Medical, 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 January 10, 2017. Regulation: 8.