OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION

OPTHALMIC QUALITY SUNGLASSES, NON-PRESCRIPTION is an FDA 510(k)-cleared medical device (K900877) manufactured by Sunglass Originals, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 26, 1990. Regulation: 8.