SUNGLASSES, NON-PRESCRIPTION (POLINELLI)

SUNGLASSES, NON-PRESCRIPTION (POLINELLI) is an FDA 510(k)-cleared medical device (K910127) manufactured by The Limited Stores, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 13, 1991. Regulation: 8.