BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 is an FDA 510(k)-cleared medical device (K072097) manufactured by Medical Select, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2007. Regulation: 8.