
Galil Medical, Inc.
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Visual-ICE Cryoablation System, Software Revision 1.3.1 is an FDA 510(k)-cleared medical device (K143564) manufactured by Galil 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 March 4, 2015. Regulation: 8.