SILHOUETTE, SUNLIMETED,ADIDAS

SILHOUETTE, SUNLIMETED,ADIDAS is an FDA 510(k)-cleared medical device (K944160) manufactured by Silhouette Optical , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 27, 1994. Regulation: 8.