PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)

PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) is an FDA 510(k)-cleared medical device (K914407) manufactured by Promedex, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 30, 1991. Regulation: 8.