
Klafs Sunlight Corp.
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METEC HELARIUM LOUNGE & SKY UNITS is an FDA 510(k)-cleared medical device (K812225) manufactured by Klafs Sunlight Corp.. 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 14, 1982. Regulation: 8.