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510(k) K202448

Device
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Applicant
Alcon Laboratories, Inc.
510(k) number
K202448
Product code
MVN
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-22
Date received
2020-08-26
Regulation
886.5925
Classification name
Lens, Contact, (Disposable)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sherri Lakota
Address
6201 S. Fwy. Fort Worth TX US 76134 76134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MVN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.2020-08-21
K150630Eye 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 WearYung Sheng Optical Co., Ltd.2015-06-15
K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd.2015-01-16
K130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.2013-07-26
K112192NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSBausch & Lomb, Inc.2011-10-25
K080632CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENSClearlab SG Pte, Ltd.2008-10-15
K080755SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENSBausch & Lomb, Inc.2008-06-10
K073060CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARInnova Vision, Inc.2007-11-29
K061948PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENSCooperVision, Inc.2006-11-22
K061157SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENSBausch & Lomb2006-06-22
K052832SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSESSauflon Pharmaceuticals, Ltd.2006-05-15
K053191DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENSInnova Vision, Inc.2006-05-12
K051900ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEARJohnson & Johnson Vision Care, Inc.2005-08-12
K050065FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVESCiba Vision Corporation2005-05-27
K050213FRESHLOOK ONE-DAY COLOR CONTACT LENSCiba Vision Corporation2005-03-28