Data / Medical devices / United States / CooperVision, Inc.

CooperVision, Inc.: FDA-registered device maker in Victor, NY, United States, 26 510(k) clearances and 6 PMA approvals

Name: CooperVision, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CooperVision, Inc. is registered with the FDA (registration 3011771819) in Victor, NY, United States. It lists 5 device types. The FDA files 26 510(k) clearances and 6 PMA approvals under its listings, the newest dated January 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch CooperVision, Inc.

FDA registration number: 3011771819
Address: 209 High Point Suite 100, Victor, NY, United States, 14564
Owner or operator: COOPERVISION, INC. (9929062)
Roles: Complaint file establishment
First device listed: November 14, 2005
Registered through: 2026
Brand names listed: Avaira Vitality Sphere, Avaira Vitality Toric, BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Soft Lens Products	LPN	2	Complaint file establishment	accessdata.fda.gov
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia	QIT	3	Complaint file establishment	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Complaint file establishment	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Complaint file establishment	accessdata.fda.gov
Lenses, Soft Contact, Extended Wear	LPM	3	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 25, 2024	K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
February 4, 2022	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
October 26, 2021	K213164	Avaira Vitality	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
October 20, 2020	K202756	Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
April 29, 2019	K190965	MyDay	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
December 11, 2018	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
July 13, 2016	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
August 30, 2013	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
August 5, 2013	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	Substantially Equivalent	Sauflon Pharmaceuticals, Ltd.	accessdata.fda.gov
July 26, 2013	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	Substantially Equivalent	Sauflon Pharmaceuticals, Ltd.	accessdata.fda.gov
May 30, 2013	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
May 15, 2013	K130734	SAUFLON MULTIPURPOSE SOLUTION	LPN	Substantially Equivalent	Sauflon Pharmaceuticals, Ltd.	accessdata.fda.gov
December 21, 2011	K112302	PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
January 5, 2010	K091339	BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
November 22, 2006	K061948	PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS	MVN	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
December 6, 2005	K052560	BIOFINITY (COMFILCON A) SOFT CONTACT LENS	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
November 7, 2003	K032873	PROCLEAR COMPATIBLES MULTIFOCAL	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
June 4, 2002	K020389	BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS	MVN	Substantially Equivalent	Ocular Sciences	accessdata.fda.gov
April 26, 2002	K020392	FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR	LPL	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov
October 12, 2001	K012425	BIOMEDICS UV MULTIFOCAL	LPL	Substantially Equivalent	Ocular Sciences Puerto Rico, Inc.	accessdata.fda.gov
January 6, 2001	K003136	OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS	LPL	Substantially Equivalent	Ocular Sciences Puerto Rico, Inc.	accessdata.fda.gov
December 10, 1999	K983637	ACTIFRESH 400 LENS	LPL	Substantially Equivalent	Hydron , Ltd.	accessdata.fda.gov
January 29, 1999	K982947	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS	LPL	Substantially Equivalent	Ocular Sciences Puerto Rico, Inc.	accessdata.fda.gov
January 21, 1999	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	Substantially Equivalent	Ocular Sciences Puerto Rico, Inc.	accessdata.fda.gov
August 20, 1997	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	Substantially Equivalent	Ocular Sciences Puerto Rico, Inc.	accessdata.fda.gov
April 3, 1997	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	Substantially Equivalent	Biocompatibles Eyewear, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 15, 2019	P180035	MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear	QIT	34	February 17, 2026	accessdata.fda.gov
November 19, 2008	P080011	BIOFINITY (COMFILCON A)	LPM	201	September 2, 2026	accessdata.fda.gov
September 19, 1989	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	53	December 11, 2025	accessdata.fda.gov
January 31, 1986	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	82	September 1, 2020	accessdata.fda.gov
April 6, 1979	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	54	September 10, 2019	accessdata.fda.gov
June 18, 1976	N17679	TETRAFILCON A	LPM	34	November 23, 2018	accessdata.fda.gov

Compare with other makers

Updated February 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.