
Cooper-Hewitt Electric Co.
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SPERTILITE PHOTOTHERAPY LAMP is an FDA 510(k)-cleared medical device (K862608) manufactured by Cooper-Hewitt Electric Co.. 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 August 5, 1986. Regulation: 8.