Cleared Traditional

K043503 - VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
(FDA 510(k) Clearance)

K043503 · Visx, Incorporated · Ophthalmic device

Apr 2005

Decision

106d

Days

Class 2

Risk

K043503 is an FDA 510(k) clearance for the VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).

Submitted by Visx, Incorporated (Santa Clara, US). The FDA issued a Cleared decision on April 5, 2005, 106 days after receiving the submission on December 20, 2004.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K043503 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 20, 2004
Decision Date	April 05, 2005
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF