LULLABY LED PHOTTHERAPY SYSTEM

LULLABY LED PHOTTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K120168) manufactured by Wipro GE Healthcare Private, Ltd.. 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 May 1, 2012. Regulation: 8.