DISCO SUNGLASSES (NON-PRESCRIPTION)

DISCO SUNGLASSES (NON-PRESCRIPTION) is an FDA 510(k)-cleared medical device (K900387) manufactured by Le-I Electronic Co. , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 27, 1990. Regulation: 8.