
Sunmaker Tanning Systems, Ltd.
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EXPRESS TAN SUN CANOPY is an FDA 510(k)-cleared medical device (K854111) manufactured by Sunmaker Tanning Systems, Ltd.. 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 November 7, 1985. Regulation: 8.