THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES

THEO NON-PRESCRIPTION SUNGLASSES/SPECTACLE FRAMES is an FDA 510(k)-cleared medical device (K924938) manufactured by Eyeworks 3. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 5, 1993. Regulation: 8.