
Heat IN A Click, LLC
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Looper (Model: ZX-579S) is an FDA 510(k)-cleared medical device (K202055) manufactured by Heat IN A Click, 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 April 15, 2021. Regulation: 8.