SPECTACLE SUNGLASSES(NON-PRESCRIPTION)

SPECTACLE SUNGLASSES(NON-PRESCRIPTION) is an FDA 510(k)-cleared medical device (K953629) manufactured by Lowinger Holdings, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 22, 1995. Regulation: 8.