Cleared Traditional

VARILUX VISIONPRINT SYSTEM (VPS) (K033949) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033949 · Essilor Intl. · Ophthalmic device
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Jul 2004
Decision
196d
Days
Class 2
Risk

K033949 is an FDA 510(k) clearance for the VARILUX VISIONPRINT SYSTEM (VPS). Classified as Monitor, Eye Movement (product code HLL), Class II - Special Controls.

Submitted by Essilor Intl. (Washington, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 196 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1510 - 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.

View all Essilor Intl. devices

Submission Details

510(k) Number K033949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2003
Decision Date July 02, 2004
Days to Decision 196 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 110d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLL Monitor, Eye Movement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1510
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.