LASERMED* GOGGLES AND SPECTACLES

LASERMED* GOGGLES AND SPECTACLES is an FDA 510(k)-cleared medical device (K894835) manufactured by Glendale Protective Technologies, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 1989. Regulation: 8.