Cleared Traditional

K083288 - DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER

K083288 is an FDA 510(k) clearance for DISCON PLUS (ETAFILCON A) CONTACT LENS ..., manufactured by Innova Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K083288 · Innova Vision, Inc. · Ophthalmic device
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Sep 2009
Decision
300d
Days
Class 2
Risk

K083288 is an FDA 510(k) clearance for the DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Innova Vision, Inc. (Flagstaff, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Innova Vision, Inc. devices

FDA 510(k) Submission Details - K083288

510(k) Number K083288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2008
Decision Date September 03, 2009
Days to Decision 300 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
190d slower than avg
Panel avg: 110d · This submission: 300d
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 444
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K083288.
SAVIEW 58 UV
K092852 · St. shine Optical Co., Ltd. · Mar 2010
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SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
K090806 · Safilens, S.R.L. · Dec 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K082879 · I-See Vision Technology, Inc. · Jun 2009
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
K082880 · I-See Vision Technology, Inc. · Jun 2009
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K082883 · I-See Vision Technology, Inc. · Jun 2009