Cleared Special

K113759 - AVAIRA (ENFILCON A) CONTACT LENS

K113759 is an FDA 510(k) clearance for AVAIRA (ENFILCON A) CONTACT LENS, manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Special 510(k) pathway after a 104-day FDA review.

K113759 · CooperVision, Inc. · Ophthalmic device
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Apr 2012
Decision
104d
Days
Class 2
Risk

K113759 is an FDA 510(k) clearance for the AVAIRA (ENFILCON A) 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 April 3, 2012 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all CooperVision, Inc. devices

FDA 510(k) Submission Details - K113759

510(k) Number K113759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date April 03, 2012
Days to Decision 104 days
Submission Type Special
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
Modification to existing cleared device.

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 348
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K113759.
BAUSCH + LOMB NESOFILCON A CONTACT LENS
K113703 · Bausch & Lomb, Incorporated · Jun 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K110835 · GEO MEDICAL CO., LTD. · Apr 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
K120028 · Pegavision Corporation · Apr 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
K113168 · Ciba Vision Corporation · Mar 2012
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
K112302 · CooperVision, Inc. · Dec 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · CooperVision, Inc. · Dec 2011