Cleared Traditional

K043503 - VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1

K043503 is an FDA 510(k) clearance for VISX CUSTOMVUE SLIT ILLUMINATOR WITH DE..., manufactured by Visx, Incorporated. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K043503 · Visx, Incorporated · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Visx, Incorporated (Santa Ana, US). The FDA issued a Cleared decision on April 5, 2005 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K043503

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 105
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K043503.
LUXVISION SLIT LAMP
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K060869 · Rightmedical Products, LLC · May 2006
VISION-TECH YZ SLIT LAMP, MODEL 66
K033190 · Suzhou 66 Vision-Tech Co., Ltd. · Dec 2003
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
K012416 · Nidek Technologies Srl · Oct 2001
K043503 · VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
Download PDF FDA Summary Visx, Incorporated