MODIFICATION OF SUNTANA SUN SYSTEM BED

MODIFICATION OF SUNTANA SUN SYSTEM BED is an FDA 510(k)-cleared medical device (K861989) manufactured by Hawaiian Tan Spa. 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 June 8, 1986. Regulation: 8.