Cleared Traditional

K033969 - ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

K033969 is an FDA 510(k) clearance for ACUVUE 2 COLOURS BRAND (ETAFILCON A) SO..., manufactured by Vistakon. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K033969 · Vistakon · Ophthalmic device
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Feb 2004
Decision
44d
Days
Class 2
Risk

K033969 is an FDA 510(k) clearance for the ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Vistakon (Jacksonville, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vistakon devices

FDA 510(k) Submission Details - K033969

510(k) Number K033969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date February 04, 2004
Days to Decision 44 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
66d faster than avg
Panel avg: 110d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 295
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K033969.
COOPER PROSTHETIC
K042435 · CooperVision, Inc. · Oct 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
K041138 · CooperVision, Inc. · Jul 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
K033919 · Ciba Vision Corporation · Mar 2004
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · CooperVision, Inc. · Nov 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
K023987 · Contamac, Ltd. · Feb 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
K023989 · Contamac, Ltd. · Feb 2003