
Psoralite Corp.
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PSORALITE 12800 SERIES is an FDA 510(k)-cleared medical device (K864510) manufactured by Psoralite 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 February 3, 1987. Regulation: 8.