
Edap Technomed, Inc.
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Ablatherm Fusion is an FDA 510(k)-cleared medical device (K172285) manufactured by Edap Technomed, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2017. Regulation: 8.