Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008586477

FEI Number

3008586477

Entity Name

CooperVision Manufacturing, LTD.

City/State/Country

Wide Lane Southampton, GB

Establishment Address

Mountpark, Unit 1, Wide Lane Southampton SO18 2FA, GB

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

COOPERVISION, INC. (Owner Number: 9929062)

Owner / Operator Contact Address

6101 Bollinger Canyon Road, Suite 500, San Ramon, CA 94583, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P850079

All Registered Proprietary Names

Clariti 1 Day Clariti 1 Day Multifocal Clariti 1 Day Toric BIOFINITY XR BIOFINITY MULTIFOCAL BIOFINITY TORIC Biofinity Biofinity Energys Biofinity XR Toric Biofinity XR Multifocal BIOFINITY TORIC MULTIFOCAL Softmed Breathables Advanced Toric Avaira (enfilcon A) HYDRASOFT XW STANDARD (sphere) HYDRASOFT TORIC XW

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2014-09-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2007-12-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2014-11-03
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2019-01-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-01-18
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2013-06-10
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2013-06-10
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2006-04-27
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2008-12-23
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-07-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-07-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2006-04-27
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2006-04-27
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2009-01-09
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2013-09-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2013-09-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2006-04-27
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2017-03-27
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2017-03-27
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2006-04-27
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2006-04-27
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2006-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

Annette Nelson Business: CooperVision, Inc. Email: anelson@coopervision.com Phone: (925) 6604471

Related Public Records

Same Entity

COOPERVISION, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614374	CooperVision Limited	Eastleigh Hampshire, GB
1314956	COOPERVISION, INC.	SCOTTSVILLE, NY, US
3005087645	SYNERGEYES, INC.	CARLSBAD, CA, US
3012123291	CooperVision Manufacturing Costa Rica SRL	Alajuela, CR
3009108089	CooperVision CL KFT	Gyal Budapest, HU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008586477. Last updated year: 2026. Please use registration number 3008586477 when referencing this establishment in official correspondence.