VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 is an FDA 510(k)-cleared medical device (K043503) manufactured by Visx, Incorporated. 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 4, 2005. Regulation: 8.