COOPERVISION, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1314956	1314956	COOPERVISION, INC.	1	Y	2026-01-01	711 NORTH RD. SCOTTSVILLE NY US 14546
2640128	3002911336	COOPERVISION Manufacturing Puerto Rico, LLC	1	N	2026-01-01	500 ROAD 584, LOT 7 AMUELAS INDUSTRIAL PARK Juana Diaz PR US 00795
9614392	3002806417	COOPERVISION MANUFACTURING, LTD.	1	N	2026-01-01	SOUTHPOINT, HAMBLE UNIT 2 SOUTHAMPTON Hampshire GB SO31 4RF
3005724763	3005724763	COOPERVISION INC.	1	Y	2026-01-01	180 THRUWAY PARK DR. W Henrietta NY US 14586
3006514242	3006514242	CooperVision Manufacturing Ltd	1	N	2026-01-01	Delta Park Concorde Way, Segensworth North Fareham Hampshire GB PO15 5RL
3011771819	3011771819	CooperVision, Inc.	1	N	2026-01-01	209 High Point Suite 100 Victor NY US 14564
3012123291	3012123291	CooperVision Manufacturing Costa Rica SRL	1	N	2026-01-01	Zona Franca El Coyol - Building 53 Alajuela CR 20101
3005124956	3005124956	CooperVision, Inc.	1	N	2020-04-25	5870 Stoneridge Drive Pleasanton CA US 94588

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
28084	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
28092	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
28097	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
73748	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
88126	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
314154	1136168390	P890023	H55 HYDROPHILIC CONTACT LENS	LPM	1989-09-19
28084	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
28093	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
28097	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
73748	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
88126	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
314154	1502538354	P850079	HYDRASOFT (METHAFILCON B) CONTACT LENS	LPM	1986-01-31
28092	2002855707	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	1979-04-06
28097	2002855707	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	1979-04-06
73748	2002855707	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	1979-04-06
88126	2002855707	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	1979-04-06
314154	2002855707	P780007	HYDRON HYDROPHILIC CONTACT LENS	LPM	1979-04-06
28097	1568709990	P180035	MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear	QIT	2019-11-15
314154	1568709990	P180035	MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear	QIT	2019-11-15
28084	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
28092	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
28093	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
28097	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
73748	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
88126	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
314154	1785821755	P080011	BIOFINITY (COMFILCON A)	LPM	2008-11-19
88126	1511717911	N17679	TETRAFILCON A	LPM	1976-06-18
314154	1511717911	N17679	TETRAFILCON A	LPM	1976-06-18
28092	1799310638	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	1999-01-21
28097	1799310638	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	1999-01-21
73748	1799310638	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	1999-01-21
88126	1799310638	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	1999-01-21
314154	1799310638	K984046	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS	LPL	1999-01-21
88126	1954562338	K983637	ACTIFRESH 400 LENS	LPL	1999-12-10
314154	1954562338	K983637	ACTIFRESH 400 LENS	LPL	1999-12-10
28092	1265821072	K982947	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS	LPL	1999-01-29
88126	1265821072	K982947	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS	LPL	1999-01-29
314154	1265821072	K982947	BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS	LPL	1999-01-29
28097	1040324356	K973063	FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR	LPL	1997-08-26
73748	1040324356	K973063	FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR	LPL	1997-08-26
88126	1040324356	K973063	FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR	LPL	1997-08-26
28092	2063762191	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	1997-08-20
28097	2063762191	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	1997-08-20
73748	2063762191	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	1997-08-20
88126	2063762191	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	1997-08-20
314154	2063762191	K972303	OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS	LPL	1997-08-20
28093	1504669145	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	1997-04-03
28097	1504669145	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	1997-04-03
73748	1504669145	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	1997-04-03
88126	1504669145	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	1997-04-03
314154	1504669145	K970095	PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS	LPL	1997-04-03
28084	1259483067	K962185	HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS	LPL	1996-12-17
88126	1259483067	K962185	HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS	LPL	1996-12-17
28093	1535985898	K952152	PROCLEAR DAILY WEAR CONTACT LENS	LPL	1995-07-27
28097	1535985898	K952152	PROCLEAR DAILY WEAR CONTACT LENS	LPL	1995-07-27
73748	1535985898	K952152	PROCLEAR DAILY WEAR CONTACT LENS	LPL	1995-07-27
88126	1535985898	K952152	PROCLEAR DAILY WEAR CONTACT LENS	LPL	1995-07-27
28092	1563727595	K942214	H55 HYDROPHILIC CONTACT LENS	LPL	1994-07-28
28097	1563727595	K942214	H55 HYDROPHILIC CONTACT LENS	LPL	1994-07-28
73748	1563727595	K942214	H55 HYDROPHILIC CONTACT LENS	LPL	1994-07-28
88126	1563727595	K942214	H55 HYDROPHILIC CONTACT LENS	LPL	1994-07-28
28097	1620975698	K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	LPL	2024-01-25
189727	1620975698	K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	LPL	2024-01-25
314154	1620975698	K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	LPL	2024-01-25
28092	1664067048	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	LPL	2022-02-04
28093	1664067048	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	LPL	2022-02-04
28097	1664067048	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	LPL	2022-02-04
314154	1664067048	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	LPL	2022-02-04
28092	1419013554	K213164	Avaira Vitality	LPL	2021-10-26
28093	1419013554	K213164	Avaira Vitality	LPL	2021-10-26
28097	1419013554	K213164	Avaira Vitality	LPL	2021-10-26
314154	1419013554	K213164	Avaira Vitality	LPL	2021-10-26
28093	1989176848	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	2020-10-20
28097	1989176848	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	2020-10-20
189727	1989176848	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	2020-10-20
314154	1989176848	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	2020-10-20
28092	1112728322	K190965	MyDay	LPL	2019-04-29
28093	1112728322	K190965	MyDay	LPL	2019-04-29
28097	1112728322	K190965	MyDay	LPL	2019-04-29
314154	1112728322	K190965	MyDay	LPL	2019-04-29
28093	1183405081	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	2018-12-11
28097	1183405081	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	2018-12-11
73748	1183405081	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	2018-12-11
189727	1183405081	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	2018-12-11
314154	1183405081	K181920	Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	LPL	2018-12-11
28092	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
28093	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
28097	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
73748	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
88126	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
314154	1478853846	K160803	Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	LPL	2016-07-13
28092	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
28093	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
28097	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
73748	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
88126	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
314154	1687022395	K131378	SUS (STENFILCON A) CONTACT LENS	LPL	2013-08-30
28097	1289465626	K130734	SAUFLON MULTIPURPOSE SOLUTION	LPN	2013-05-15
88126	1289465626	K130734	SAUFLON MULTIPURPOSE SOLUTION	LPN	2013-05-15
314154	1289465626	K130734	SAUFLON MULTIPURPOSE SOLUTION	LPN	2013-05-15
28093	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
28097	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
73748	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
88126	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
189727	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
314154	1185919024	K130342	SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER	LPL	2013-08-05
28093	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
28097	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
73748	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
88126	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
189727	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
314154	1912497644	K130331	SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER	MVN	2013-07-26
28084	1929771401	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	2013-05-30
28093	1929771401	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	2013-05-30
73748	1929771401	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	2013-05-30
88126	1929771401	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	2013-05-30
314154	1929771401	K123202	PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS	LPL	2013-05-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LPL	124	2024-01-25
LPM	27	2008-11-19
MVN	17	2013-07-26
LPN	5	2013-05-15
LRX	2	2005-11-02
MRC	2	2001-07-17

PMA#

Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

2023-01-19

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS153 Date Received12/21/2022 Decision Date01/19/2023 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

2023-01-13

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS015 Date Received12/19/2022 Decision Date01/13/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supple...

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

2023-01-12

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS013 Date Received12/14/2022 Decision Date01/12/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

2023-01-10

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS014 Date Received12/16/2022 Decision Date01/10/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear

2022-12-21

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS152 Date Received11/29/2022 Decision Date12/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear

2022-12-07

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS151 Date Received11/09/2022 Decision Date12/07/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

2022-12-07

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS012 Date Received09/30/2022 Decision Date12/07/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supple...

Biofinity, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses

2022-11-21

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS150 Date Received10/25/2022 Decision Date11/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear

2022-10-26

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS149 Date Received09/30/2022 Decision Date10/26/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

2022-09-22

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS011 Date Received08/23/2022 Decision Date09/22/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

MiSight 1 day (omafilcon A)

2022-09-15

CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS010 Date Received08/17/2022 Decision Date09/15/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

Biofinity XR Toric, Biofinity Toric Multifocal

2022-08-18

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS148 Date Received07/21/2022 Decision Date08/18/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Biofinity Sphere, Biofinity Toric

2022-08-08

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS147 Date Received07/11/2022 Decision Date08/08/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

2022-07-25

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS146 Date Received04/27/2022 Decision Date07/25/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Re...

Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an

2022-05-10

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP870024 Supplement NumberS062 Date Received04/15/2022 Decision Date05/10/2022 Product Code MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Paragon Z CRT, Paragon Z CRT Dual Axis

2022-05-10

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP050031 Supplement NumberS009 Date Received04/15/2022 Decision Date05/10/2022 Product Codes NUU MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement R...

Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact

2022-05-03

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS145 Date Received04/06/2022 Decision Date05/03/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont

2022-04-27

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS143 Date Received03/31/2022 Decision Date04/27/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...

Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca

2022-04-14

CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS140 Date Received03/17/2022 Decision Date04/14/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason...