OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX

OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX is an FDA 510(k)-cleared medical device (K943236) manufactured by Optiline Imports and Trade, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 1, 1994. Regulation: 8.