510(k) K043503

VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 by Visx, Incorporated — Product Code HJO

K043503 is an FDA 510(k) premarket notification submitted by Visx, Incorporated for the device "VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1". The FDA issued a decision of Substantially Equivalent on April 5, 2005. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Visx, Incorporated has at least 1 other 510(k) clearance on record.