
Ciba Vision Corporation
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FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN is an FDA 510(k)-cleared medical device (K020139) manufactured by Ciba Vision Corporation. 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 8, 2002. Regulation: 8.