Cleared Traditional

K950294 - FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS

K950294 is an FDA 510(k) clearance for FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS, manufactured by Flexlens, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K950294 · Flexlens, Inc. · Ophthalmic device
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Apr 1996
Decision
442d
Days
Class 2
Risk

K950294 is an FDA 510(k) clearance for the FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Flexlens, Inc. (Englewood, US). The FDA issued a Cleared decision on April 11, 1996 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

FDA 510(k) Submission Details - K950294

510(k) Number K950294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date April 11, 1996
Days to Decision 442 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
332d slower than avg
Panel avg: 110d · This submission: 442d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K950294.
HORIZON/WESTHIN 55-G
K962121 · Westcon Contact Lens Co., Inc. · Aug 1996
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
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960926 · Unilens Corp., USA · Apr 1996
W-55 (METHAFILON A) CONTACT LENS
K954524 · Westcon Contact Lens Co., Inc. · Mar 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960376 · Unilens Corp., USA · Mar 1996
K950294 · FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
Download PDF Flexlens, Inc.