Cleared Traditional

K082879 - EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K082879 is an FDA 510(k) clearance for EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) ..., manufactured by I-See Vision Technology, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K082879 · I-See Vision Technology, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
260d
Days
Class 2
Risk

K082879 is an FDA 510(k) clearance for the EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by I-See Vision Technology, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 16, 2009 after a review of 260 days - an extended review 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: 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.

FDA 510(k) Submission Details - K082879

510(k) Number K082879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date June 16, 2009
Days to Decision 260 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
150d slower than avg
Panel avg: 110d · This submission: 260d
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 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K082879.
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
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K090806 · Safilens, S.R.L. · Dec 2009
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
K083288 · Innova Vision, Inc. · Sep 2009
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K082880 · I-See Vision Technology, Inc. · Jun 2009
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K082883 · I-See Vision Technology, Inc. · Jun 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
K083216 · Ciba Vision Corporation · Apr 2009
K082879 · EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Download PDF FDA Summary I-See Vision Technolo…