Cleared Traditional

K963837 - HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN

K963837 is an FDA 510(k) clearance for HORIZON/WESTHIN 38 SOFBLU (POLYMACON) S..., 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.

K963837 · Westcon Contact Lens Co., Inc. · Ophthalmic device
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Dec 1996
Decision
87d
Days
Class 2
Risk

K963837 is an FDA 510(k) clearance for the HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CON.... 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 December 20, 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 - K963837

510(k) Number K963837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1996
Decision Date December 20, 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 K963837.
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · Sunsoft Corp. · Feb 1997
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
K963764 · Specialty Ultravision, Inc. · Jan 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
K964612 · Vistakon, Johnson & Johnson Vision Products, Inc. · Jan 1997
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
K962185 · CooperVision, Inc. · Dec 1996
CONTACT LENS WITH COLOR ADDITIVE
K962911 · Cal Bionics · Nov 1996
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
K963011 · Permeable Technologies, Inc. · Nov 1996