Cleared Traditional

K023530 - HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)

K023530 is an FDA 510(k) clearance for HORIZON 38 (CLEAR) AND HORIZON 38 WESTI..., 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 36-day FDA review.

K023530 · Westcon Contact Lens Co., Inc. · Ophthalmic device
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Nov 2002
Decision
36d
Days
Class 2
Risk

K023530 is an FDA 510(k) clearance for the HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED). 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 November 26, 2002 after a review of 36 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 Westcon Contact Lens Co., Inc. devices

FDA 510(k) Submission Details - K023530

510(k) Number K023530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date November 26, 2002
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
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 K023530.
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K020392 · CooperVision, Inc. · Apr 2002
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K020139 · Ciba Vision Corporation · Apr 2002
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K003071 · Ciba Vision Corporation · Dec 2000