Cleared Traditional

K954603 - DURASOFT FRESHLOOK UV COLORS

Also marketed or referenced as:
DURASOFT 3 FRESHLOOK UV LITE TINT

K954603 is an FDA 510(k) clearance for DURASOFT FRESHLOOK UV 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 92-day FDA review.

K954603 · Wesley Jessen Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
92d
Days
Class 2
Risk

K954603 is an FDA 510(k) clearance for the DURASOFT FRESHLOOK UV COLORS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Wesley Jessen Corp. (Chicago, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 92 days - within the typical 510(k) review window.

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 Wesley Jessen Corp. devices

FDA 510(k) Submission Details - K954603

510(k) Number K954603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date January 04, 1996
Days to Decision 92 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
18d faster than avg
Panel avg: 110d · This submission: 92d
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 K954603.
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
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807 · Stephen A. Dunn, Inc. · Feb 1996
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · CooperVision, Inc. · Jul 1995
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994