LL BI-FOCAL, DAILY WEAR CONTACT LENS

LL BI-FOCAL, DAILY WEAR CONTACT LENS is an FDA 510(k)-cleared medical device (K971647) manufactured by Lombart Lenses, Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 1997. Regulation: 8.