Cleared Traditional

K954524 - W-55 (METHAFILON A) CONTACT LENS

K954524 is an FDA 510(k) clearance for W-55 (METHAFILON A) CONTACT LENS, 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 181-day FDA review.

K954524 · Westcon Contact Lens Co., Inc. · Ophthalmic device
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Mar 1996
Decision
181d
Days
Class 2
Risk

K954524 is an FDA 510(k) clearance for the W-55 (METHAFILON A) CONTACT LENS. 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 March 28, 1996 after a review of 181 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 - K954524

510(k) Number K954524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date March 28, 1996
Days to Decision 181 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
71d slower than avg
Panel avg: 110d · This submission: 181d
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 278
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K954524.
SOFT-55 DAILY WEAR CONTACT LENS
K961428 · Lombart Lenses, Ltd. · May 1996
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
K950294 · Flexlens, Inc. · Apr 1996
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960926 · Unilens Corp., USA · Apr 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960376 · Unilens Corp., USA · Mar 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380 · Unilens Corp., USA · Mar 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
K960291 · Ocu-Ease Optical Products, Inc. · Mar 1996