Cleared Traditional

K962957 - RURASOFT 2 FRESHLOOK COLORS

Also marketed or referenced as:
DURASOFT 2 FRESHLOOK LITETINT

K962957 is an FDA 510(k) clearance for RURASOFT 2 FRESHLOOK COLORS, manufactured by Wesley Jessen Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K962957 · Wesley Jessen Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
63d
Days
Class 2
Risk

K962957 is an FDA 510(k) clearance for the RURASOFT 2 FRESHLOOK COLORS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Wesley Jessen Corp. (Des Plaines, US). The FDA issued a Cleared decision on October 1, 1996 after a review of 63 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 Wesley Jessen Corp. devices

FDA 510(k) Submission Details - K962957

510(k) Number K962957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date October 01, 1996
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
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 357
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K962957.
FLEXLENS
K961943 · Flexlens, Inc. · Oct 1996
FLEXLENS(METHAFILCON A)
K962000 · Flexlens, Inc. · Oct 1996
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
K962804 · Vistakon, Johnson & Johnson Vision Products, Inc. · Oct 1996
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K962710 · Gelflex Laboratories · Sep 1996
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
K962711 · Gelflex Laboratories · Sep 1996
HORIZON/WESTHIN 55-G
K962121 · Westcon Contact Lens Co., Inc. · Aug 1996