Cleared Traditional

K961428 - SOFT-55 DAILY WEAR CONTACT LENS

K961428 is an FDA 510(k) clearance for SOFT-55 DAILY WEAR CONTACT LENS, manufactured by Lombart Lenses, Ltd.. 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.

K961428 · Lombart Lenses, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
36d
Days
Class 2
Risk

K961428 is an FDA 510(k) clearance for the SOFT-55 DAILY WEAR CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Lombart Lenses, Ltd. (Norfolk, US). The FDA issued a Cleared decision on May 21, 1996 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.

FDA 510(k) Submission Details - K961428

510(k) Number K961428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date May 21, 1996
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K961428.
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
K962711 · Gelflex Laboratories · Sep 1996
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
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
W-55 (METHAFILON A) CONTACT LENS
K954524 · Westcon Contact Lens Co., Inc. · Mar 1996
K961428 · SOFT-55 DAILY WEAR CONTACT LENS
Download PDF FDA Summary Lombart Lenses, Ltd.