Cleared Traditional

K960291 - TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

K960291 is an FDA 510(k) clearance for TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT ..., manufactured by Ocu-Ease Optical Products, Inc.. 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.

K960291 · Ocu-Ease Optical Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
63d
Days
Class 2
Risk

K960291 is an FDA 510(k) clearance for the TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ocu-Ease Optical Products, Inc. (Pinole, US). The FDA issued a Cleared decision on March 25, 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 Ocu-Ease Optical Products, Inc. devices

FDA 510(k) Submission Details - K960291

510(k) Number K960291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date March 25, 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 278
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K960291.
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
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380 · Unilens Corp., USA · Mar 1996
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807 · Stephen A. Dunn, Inc. · Feb 1996
DURASOFT FRESHLOOK UV COLORS
K954603 · Wesley Jessen Corp. · Jan 1996
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995