Cleared Traditional

K962121 - HORIZON/WESTHIN 55-G

K962121 is an FDA 510(k) clearance for HORIZON/WESTHIN 55-G, 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 87-day FDA review.

K962121 · Westcon Contact Lens Co., Inc. · Ophthalmic device
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Aug 1996
Decision
87d
Days
Class 2
Risk

K962121 is an FDA 510(k) clearance for the HORIZON/WESTHIN 55-G. 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 August 26, 1996 after a review of 87 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 - K962121

510(k) Number K962121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date August 26, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
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 279
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K962121.
RURASOFT 2 FRESHLOOK COLORS
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GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
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BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
K961103 · Benz Research and Development Corp. · Aug 1996
SOFT-55 DAILY WEAR CONTACT LENS
K961428 · Lombart Lenses, Ltd. · May 1996
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
K950294 · Flexlens, Inc. · Apr 1996