Cleared Traditional

K031774 - HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES

K031774 is an FDA 510(k) clearance for HORIZON (METHAFILCON A) DAILY WEAR SPHE..., manufactured by Westcon Contact Lens Co., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K031774 · Westcon Contact Lens Co., Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 2004
Decision
256d
Days
Class 2
Risk

K031774 is an FDA 510(k) clearance for the HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Westcon Contact Lens Co., Inc. (Grnad Junction, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 256 days - an extended review 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: 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 Westcon Contact Lens Co., Inc. devices

FDA 510(k) Submission Details - K031774

510(k) Number K031774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2003
Decision Date February 20, 2004
Days to Decision 256 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
146d slower than avg
Panel avg: 110d · This submission: 256d
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 280
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K031774.
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