SPECTACLE SUN GLASSES (NON PRESCRIPTION)

SPECTACLE SUN GLASSES (NON PRESCRIPTION) is an FDA 510(k)-cleared medical device (K954173) manufactured by Monte Carlo Eyewear, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 2, 1995. Regulation: 8.