
CSA Medical, Inc.
Free shipping on orders over $99 · 30-day returns
truFreeze System is an FDA 510(k)-cleared medical device (K162695) manufactured by CSA 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 October 24, 2016. Regulation: 8.