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Lenses, Soft Contact, Daily Wear

FDA product code LPL · 460 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.5925
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1994-04-12 – 2026-09-17

LPL 2018-02-22

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

Applicant Menicon Co, Ltd.

K number K180004

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LPL 2017-12-13

Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Applicant Tangible Science, LLC

K number K172692

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LPL 2017-12-05

OxyPure Color Silicone Hydrogel Soft Contact Lenses

Applicant Visco Vision, Inc.

K number K171447

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LPL 2017-11-07

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Applicant Visioneering Technologies, Inc.

K number K173086

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LPL 2017-10-25

AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal

Applicant Alcon Laboratories, Inc.

K number K172600

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LPL 2017-10-18

Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

Applicant Tangible Science, LLC

K number K171125

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LPL 2017-09-18

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA

Applicant Largan Medical Co., Ltd.

K number K170286

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LPL 2017-08-09

DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Applicant Alcon Laboratories, Inc.

K number K172066

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LPL 2017-06-02

PolyDev Soft Contact Lenses

Applicant Polydev , Ltd.

K number K171157

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LPL 2017-01-04

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

Applicant Supervision Optimax Sdn Bhd

K number K162223

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LPL 2016-12-19

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K number K161739

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LPL 2016-11-30

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Applicant Alcon Laboratories, Inc.

K number K161391

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LPL 2016-10-24

Visco (olifilcon A) soft contact lens

Applicant Visco Vision, Inc.

K number K160245

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LPL 2016-10-21

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

Applicant St. shine Optical Co., Ltd.

K number K162317

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LPL 2016-10-13

AIR OPTIX COLORS

Applicant Alcon Laboratories, Inc.

K number K162596

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LPL 2016-10-12

Toricolors (hioxifilcon D) Soft Contact Lenses

Applicant Polydev , Ltd.

K number K161931

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LPL 2016-08-26

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

Applicant Vision Science Co., Ltd.

K number K161124

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LPL 2016-08-22

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Applicant Joowon Innovation Co., Ltd.

K number K161098

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LPL 2016-08-10

Hidrocor, Hidrocharme, and Natural Colors

Applicant Solotica

K number K160472

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LPL 2016-07-13

PolyDev Soft Contact Lenses

Applicant Polydev , Ltd.

K number K160977

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LPL 2016-07-13

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens

Applicant CooperVision, Inc.

K number K160803

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LPL 2016-05-26

Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016

Applicant Visco Vision, Inc.

K number K160344

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LPL 2016-05-17

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

Applicant Smart Performer Corp. , Ltd.

K number K152657

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LPL 2016-05-02

AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric

Applicant Alcon Laboratories, Inc.

K number K160609

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LPL 2016-04-08

Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Applicant INTEROJO, Inc.

K number K153766

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LPL 2016-04-08

EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

Applicant Eyeyon Medical

K number K153305

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LPL 2016-03-28

ACUVUE (senofilcon C) Soft Contact Lens

Applicant Johnson & Johnson Vision Care, Inc.

K number K160212

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LPL 2016-03-04

SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

Applicant Smart Performer Corp. , Ltd.

K number K151847

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LPL 2016-02-11

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist

Applicant Bausch & Lomb, Incorporated

K number K151918

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LPL 2016-01-20

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Applicant Alcon Laboratories, Inc.

K number K153643

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LPL 2016-01-20

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Applicant Alcon Laboratories, Inc.

K number K153642

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LPL 2013-12-23

AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS

Applicant CooperVision, Inc.

K number K133627

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LPL 2013-12-23

EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Yung Sheng Optical Co., Ltd.

K number K132854

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LPL 2013-12-20

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS

Applicant Bausch & Lomb, Incorporated

K number K132715

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LPL 2013-12-17

IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)

Applicant Alden Optical Labs., Inc.

K number K133079

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LPL 2013-09-11

BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,

Applicant Bausch & Lomb, Inc.

K number K131208

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LPL 2013-08-30

SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)

Applicant St. shine Optical Co., Ltd.

K number K132146

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LPL 2013-08-30

SUS (STENFILCON A) CONTACT LENS

Applicant CooperVision, Inc.

K number K131378

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LPL 2013-08-30

EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS

Applicant Jiangsu Horien Contact Lens Co., Ltd.

K number K130931

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LPL 2013-08-05

SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

Applicant Sauflon Pharmaceuticals, Ltd.

K number K130342

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LPL 2013-06-17

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

Applicant Dreamcon Co., Ltd.

K number K123431

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LPL 2013-05-30

PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS

Applicant CooperVision, Inc.

K number K123202

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LPL 2013-05-13

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

Applicant The Lagado Corp.

K number K120756

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LPL 2013-04-23

AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

Applicant Pegavision Corporation

K number K123973

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LPL 2013-03-29

SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS

Applicant St. shine Optical Co., Ltd.

K number K123484

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LPL 2013-03-19

ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S

Applicant Soflex Limited

K number K122220

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LPL 2013-02-21

DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL

Applicant Ciba Vision Corporation

K number K123994

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LPL 2013-02-15

FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC

Applicant Oculus Private Limited

K number K122315

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LPL 2012-12-20

BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI

Applicant Bausch & Lomb, Inc.

K number K122575

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LPL 2012-12-12

ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Soflex Limited

K number K122213

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LPL 2012-10-26

SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS

Applicant St. shine Optical Co., Ltd.

K number K121201

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LPL 2012-10-05

CVUE ADVANCED HYDRA VUE

Applicant Unilens Corp., USA

K number K121652

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LPL 2012-09-18

ISIGHT

Applicant C&E GP Specialists, Inc.

K number K121519

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LPL 2012-08-23

AVT NATURASOFT

Applicant Advanced Vision Technologies

K number K121324

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LPL 2012-08-17

CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION

Applicant Innova Vision, Inc.

K number K112373

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LPL 2012-06-05

BAUSCH + LOMB NESOFILCON A CONTACT LENS

Applicant Bausch & Lomb, Incorporated

K number K113703

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LPL 2012-04-26

GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

Applicant GEO MEDICAL CO., LTD.

K number K110835

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LPL 2012-04-17

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES

Applicant Pegavision Corporation

K number K120028

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LPL 2012-04-03

AVAIRA (ENFILCON A) CONTACT LENS

Applicant CooperVision, Inc.

K number K113759

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LPL 2012-03-30

DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC

Applicant Ciba Vision Corporation

K number K113168

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LPL 2011-12-21

PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES

Applicant CooperVision, Inc.

K number K112302

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LPL 2011-12-02

BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC

Applicant CooperVision, Inc.

K number K113267

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LPL 2011-12-02

AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL

Applicant CooperVision, Inc.

K number K113245

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LPL 2011-11-08

CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)

Applicant Abbconcise Optical Group, LLC

K number K111267

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LPL 2011-11-02

SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS

Applicant The See Clear Company, Inc.

K number K111345

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LPL 2011-09-15

PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC

Applicant CooperVision, Inc.

K number K111966

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LPL 2011-09-08

FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI

Applicant Oculus Private Limited

K number K103132

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LPL 2011-07-28

ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

Applicant Soflex Limited

K number K110261

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LPL 2011-06-29

PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT

Applicant CooperVision, Inc.

K number K110099

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LPL 2011-04-28

ONE DAY FLAT PACK

Applicant Menicon Co, Ltd.

K number K102895

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LPL 2011-04-26

NOVAKONE SPHERICAL AND TORIC LENSES

Applicant Alden Optical Labs., Inc.

K number K102557

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LPL 2011-04-20

SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,

Applicant Unilens Corp., USA

K number K110452

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LPL 2010-10-28

CVUE ADVANCED DEFINITIVE

Applicant Unilens Corp., USA

K number K100456

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LPL 2010-10-28

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

Applicant X-Cel Contacts, Inc.

K number K100443

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LPL 2010-10-28

METRO SOFT

Applicant Metro Optics of Austin, Inc.

K number K100244

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LPL 2010-09-14

INTELLIWAVE3

Applicant Art Optical Contact Lens, Inc.

K number K100221

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LPL 2010-08-09

BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS

Applicant Benz Research and Development Corp.

K number K101122

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LPL 2010-06-25

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES

Applicant Alden Optical Labs., Inc.

K number K091327

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LPL 2010-05-21

VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER

Applicant Johnson & Johnson Vision Care, Inc.

K number K100349

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LPL 2010-03-11

SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant St. shine Optical Co., Ltd.

K number K092852

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LPL 2010-01-05

BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

Applicant CooperVision, Inc.

K number K091339

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LPL 2009-12-18

SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON

Applicant Safilens, S.R.L.

K number K090806

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LPL 2009-09-03

DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER

Applicant Innova Vision, Inc.

K number K083288

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LPL 2009-06-16

EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR

Applicant I-See Vision Technology, Inc.

K number K082883

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LPL 2009-06-16

EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS

Applicant I-See Vision Technology, Inc.

K number K082880

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LPL 2009-06-16

EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant I-See Vision Technology, Inc.

K number K082879

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LPL 2009-04-14

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

Applicant Ciba Vision Corporation

K number K083216

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LPL 2008-12-17

POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Polyvue Distribution, Inc.

K number K080794

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LPL 2008-09-29

PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR

Applicant CooperVision, Inc.

K number K081865

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LPL 2008-09-11

CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

Applicant Unilens Corp., USA

K number K082393

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LPL 2008-07-23

REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

Applicant Metro Optics of Austin, Inc.

K number K080512

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LPL 2008-07-03

INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

Applicant Art Optical Contact Lens, Inc.

K number K073621

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LPL 2008-04-22

WESTCON HORIZON 49% (HIOXIFILCON B)

Applicant Westcon Contact Lens Co.

K number K080686

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LPL 2008-03-03

VISTAKON (NARAFILCON) A SOFT CONTACT LENS

Applicant Johnson & Johnson Vision Care, Inc.

K number K073485

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LPL 2008-02-28

CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES

Applicant Ciba Vision Corporation

K number K073459

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LPL 2008-01-24

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

Applicant Ciba Vision Corporation

K number K072777

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LPL 2008-01-04

AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

Applicant CooperVision, Inc.

K number K071736

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LPL 2007-08-06

BENZ-G 4X HIOXIFILCON D

Applicant Benz Research and Development Corp.

K number K062854

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LPL 2007-06-07

CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

Applicant Innova Vision, Inc.

K number K062541

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LPL 2007-03-12

FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR

Applicant X-Cel Contacts

K number K070308

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