FDA 510(k) Applications Submitted by CooperVision, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K131378 05/14/2013 SUS (STENFILCON A) CONTACT LENS COOPERVISION, INC.
K133627 11/26/2013 AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS COOPERVISION, INC.
K962185 06/06/1996 HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS COOPERVISION, INC.
K963013 07/30/1996 PREFERENCE 60 AND PREFERENCE 60 TORIC COOPERVISION, INC.
K020392 02/06/2002 FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR COOPERVISION, INC.
K000384 02/07/2000 FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX COOPERVISION, INC.
K980649 02/19/1998 PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS COOPERVISION, INC.
K990606 02/23/1999 TETRAFILCON A COOPERVISION, INC.
K050717 03/21/2005 PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC COOPERVISION, INC.
K001089 04/04/2000 POLYMACON COOPERVISION, INC.
K001090 04/04/2000 METHAFILCON A COOPERVISION, INC.
K081865 07/01/2008 PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR COOPERVISION, INC.
K002625 08/23/2000 METHAFILCON A COOPERVISION, INC.
K993252 09/28/1999 METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP COOPERVISION, INC.
K042435 09/08/2004 COOPER PROSTHETIC COOPERVISION, INC.
K041138 04/30/2004 LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS COOPERVISION, INC.
K042824 10/12/2004 FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC.
K113245 11/02/2011 AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL COOPERVISION, INC.
K113267 11/04/2011 BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC COOPERVISION, INC.
K071736 06/26/2007 AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC.
K052560 09/16/2005 BIOFINITY (COMFILCON A) SOFT CONTACT LENS COOPERVISION, INC.
K123202 10/12/2012 PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS COOPERVISION, INC.
K113759 12/21/2011 AVAIRA (ENFILCON A) CONTACT LENS COOPERVISION, INC.
K091339 05/06/2009 BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC.
K061948 07/10/2006 PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS COOPERVISION, INC.
K111966 07/11/2011 PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC COOPERVISION, INC.
K220070 01/10/2022 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens CooperVision, Inc.
K190965 04/12/2019 MyDay CooperVision, Inc.
K191763 07/01/2019 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC CooperVision, Inc.
K181920 07/18/2018 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc.
K202756 09/21/2020 Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) CooperVision, Inc.
K160803 03/23/2016 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc.
K110099 01/13/2011 PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT COOPERVISION, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact