Cleared Traditional

K160803 - Avaira Vitality (fanfilcon A) Soft (Hyd...

K160803 is the FDA 510(k) clearance for Avaira Vitality (fanfilcon A) Soft (Hyd... by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K160803 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
112d
Days
Class 2
Risk

K160803 is an FDA 510(k) clearance for the Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 13, 2016 after a review of 112 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 CooperVision, Inc. devices

Submission Details

510(k) Number K160803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2016
Decision Date July 13, 2016
Days to Decision 112 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
2d slower than avg
Panel avg: 110d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
NCT02555722 Completed Interventional Industry-sponsored

Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

92
Patients (actual)
6
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Myopia
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Eric M White, OD
Sponsor CooperVision, Inc. (industry)
Started 2015-09-21 → Primary completion 2016-01-27 → Completed 2016-05-01
Primary outcome
Epithelial Edema - Fanfilcon A Lens (Test)
Secondary outcome
Comfort - Fanfilcon A Lens (Test)
View full study on ClinicalTrials.gov

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K160803.
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K172066 · Alcon Laboratories, Inc. · Aug 2017
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K161391 · Alcon Laboratories, Inc. · Nov 2016
AIR OPTIX COLORS
K162596 · Alcon Laboratories, Inc. · Oct 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
K160609 · Alcon Laboratories, Inc. · May 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K153642 · Alcon Laboratories, Inc. · Jan 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · Alcon Laboratories, Inc. · Jan 2016