FDA 510(k) Applications for Medical Device Product Code "MVN"
(Lens, Contact, (Disposable))

FDA 510(k) Number Applicant Device Name Decision Date
K202448 Alcon Laboratories, Inc. DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal 09/22/2020
K202036 Alcon Laboratories, Inc. Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal 08/21/2020
K061157 BAUSCH & LOMB SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS 06/22/2006
K011718 BAUSCH & LOMB, INC. BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT 07/25/2001
K112192 BAUSCH & LOMB, INC. NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS 10/25/2011
K080755 BAUSCH & LOMB, INC. SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS 06/10/2008
K010636 CIBA VISION CORPORATION FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT 03/23/2001
K003826 CIBA VISION CORPORATION FOCUS DAILIES PROGRESSIVES 03/08/2001
K984273 CIBA VISION CORPORATION FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS 01/25/1999
K050065 CIBA VISION CORPORATION FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES 05/27/2005
K033701 CIBA VISION CORPORATION FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES 12/15/2003
K050213 CIBA VISION CORPORATION FRESHLOOK ONE-DAY COLOR CONTACT LENS 03/28/2005
K992446 CIBA VISION JOHNS CREEK MFG. DAILIES (NELFILCON A) ONE-DAY 08/18/1999
K003586 CIBA-GEIGY CORP. FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES 02/08/2001
K080632 CLEARLAB SG PTE LTD. CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS 10/15/2008
K993252 COOPERVISION, INC. METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP 11/24/1999
K061948 COOPERVISION, INC. PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS 11/22/2006
K073060 INNOVA VISION INC. CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR 11/29/2007
K053191 INNOVA VISION INC. DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS 05/12/2006
K051900 JOHNSON & JOHNSON VISION CARE, INC. ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR 08/12/2005
K020389 OCULAR SCIENCES BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS 06/04/2002
K130331 SAUFLON PHARMACEUTICALS, LTD. SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER 07/26/2013
K052832 SAUFLON PHARMACEUTICALS, LTD. SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES 05/15/2006
K143190 YUNG SHENG OPTICAL CO., LTD. Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens 01/16/2015
K150630 YUNG SHENG OPTICAL CO., LTD. Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear 06/15/2015


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