Emprint Ablation System with Thermosphere Technology

Emprint Ablation System with Thermosphere Technology is an FDA 510(k)-cleared medical device (K200796) manufactured by Covidien, 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 August 25, 2020. Regulation: 8.