Cleared Traditional

K133176 - AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL

K133176 is an FDA 510(k) clearance for AIR OPTIX COLORS, manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K133176 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
104d
Days
Class 2
Risk

K133176 is an FDA 510(k) clearance for the AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on January 29, 2014 after a review of 104 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 Ciba Vision Corporation devices

FDA 510(k) Submission Details - K133176

510(k) Number K133176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 29, 2014
Days to Decision 104 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
6d faster than avg
Panel avg: 110d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01338402 Completed Interventional Industry-sponsored

Evaluation of the Performance of AIR OPTIX® COLORS

47
Patients (actual)
1
Site
Single blind
Masking
Condition studied Myopia
Study design Single group
Eligibility All sexes · 17 Years+
Principal investigator Desmond Fonn, MOptom, FAAO
Sponsor CIBA VISION (industry)
Started 2011-04-01 → Primary completion 2012-03-01
Primary outcome
Visual Acuity
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 190
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K133176.
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BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K131208 · Bausch & Lomb, Inc. · Sep 2013