SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2

SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 is an FDA 510(k)-cleared medical device (K910597) manufactured by Radix Group Intl.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 25, 1991. Regulation: 8.