FACONNABLE EYEWEAR (SUNGLASSES)

FACONNABLE EYEWEAR (SUNGLASSES) is an FDA 510(k)-cleared medical device (K943568) manufactured by Blink Designs, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 10, 1994. Regulation: 8.