NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit is an FDA 510(k)-cleared medical device (K142956) manufactured by Integrated Healing Technologies. 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 February 23, 2015. Regulation: 8.