Cleared Traditional

K033949 - VARILUX VISIONPRINT SYSTEM (VPS)

K033949 is an FDA 510(k) clearance for VARILUX VISIONPRINT SYSTEM (VPS), manufactured by Essilor Intl.. The device is a Class 2 Ophthalmic device with product code HLL cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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

FDA 510(k) Submission Details - K033949

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.

HLL Device Classification - Class 2, Special Controls

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.