Medical Device Manufacturer · GB , Southampton

CooperVision, Inc.

97 submissions · 94 cleared · Since 1978
97
Total
94
Cleared
0
Denied

CooperVision, Inc. — FDA 510(k) Submissions

CooperVision, Inc. has submitted 97 FDA 510(k) premarket notifications since 1978, of which 94 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lenses, Soft Contact, Daily Wear, Unit, Phacofragmentation, Instrument, Vitreous Aspiration And Cutting, Ac-powered, System, Imaging, Pulsed Echo, Ultrasonic, Laser, Ophthalmic . Use the specialty filter in the sidebar to narrow results.

97 devices
1–25 of 97
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
K234127 · LPL Lenses, Soft Contact,... · Ophthalmic
Jan 2024 28d
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
K220070 · LPL Lenses, Soft Contact,... · Ophthalmic
Feb 2022 25d
Avaira Vitality
K213164 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2021 28d
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
K202756 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2020 29d
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
K191763 · LPL Lenses, Soft Contact,... · Ophthalmic
Mar 2020 266d
MyDay
K190965 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2019 17d
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
K181920 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2018 146d
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · LPL Lenses, Soft Contact,... · Ophthalmic
Jul 2016 112d
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2013 27d
SUS (STENFILCON A) CONTACT LENS
K131378 · LPL Lenses, Soft Contact,... · Ophthalmic
Aug 2013 108d
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2013 230d
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2012 104d
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
K112302 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2011 132d
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2011 30d
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
K113267 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2011 28d
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · LPL Lenses, Soft Contact,... · Ophthalmic
Sep 2011 66d
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
K110099 · LPL Lenses, Soft Contact,... · Ophthalmic
Jun 2011 167d
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · LPL Lenses, Soft Contact,... · Ophthalmic
Jan 2010 244d
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · LPL Lenses, Soft Contact,... · Ophthalmic
Sep 2008 90d
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · LPL Lenses, Soft Contact,... · Ophthalmic
Jan 2008 192d
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · MVN Lens, Contact, (disposable) · Ophthalmic
Nov 2006 135d
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2005 81d
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
K050717 · LPL Lenses, Soft Contact,... · Ophthalmic
May 2005 53d
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · LPL Lenses, Soft Contact,... · Ophthalmic
Nov 2004 35d
COOPER PROSTHETIC
K042435 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2004 48d

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