SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,

SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, is an FDA 510(k)-cleared medical device (K110452) manufactured by Unilens Corp., USA. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2011. Regulation: 8.