PAINACEA MODEL XR8 INFRARED HEAT LAMP

PAINACEA MODEL XR8 INFRARED HEAT LAMP is an FDA 510(k)-cleared medical device (K051046) manufactured by Atlantis Luminescent Products, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 2005. Regulation: 8.