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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 2006-11-14

CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

Applicant Ciba Vision Corporation

K number K062262

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LPL 2006-11-01

VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)

Applicant Johnson & Johnson Vision Care, Inc.

K number K062614

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LPL 2006-05-18

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES

Applicant Specialeyes, LLC

K number K060821

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LPL 2006-05-15

AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS

Applicant Clearlab Pte , Ltd.

K number K052290

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LPL 2006-03-10

MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)

Applicant Mi Gwang Contact Lens Co., Ltd.

K number K051477

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LPL 2005-12-15

MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS

Applicant Marietta Vision

K number K052606

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LPL 2005-12-06

BIOFINITY (COMFILCON A) SOFT CONTACT LENS

Applicant CooperVision, Inc.

K number K052560

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LPL 2005-11-10

ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL

Applicant Alden Optical Labs., Inc.

K number K052703

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LPL 2005-08-16

55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Optical Connection, Inc.

K number K051095

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LPL 2005-08-12

DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Innova Vision, Inc.

K number K051129

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LPL 2005-07-18

EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)

Applicant Hydrogel Vision Corporation

K number K051430

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LPL 2005-07-01

55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant United Contact Lens, Inc.

K number K051184

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LPL 2005-05-18

PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Applicant Bausch & Lomb, Inc.

K number K050948

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LPL 2005-05-13

PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC

Applicant CooperVision, Inc.

K number K050717

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LPL 2005-04-26

MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS

Applicant Bausch & Lomb, Inc.

K number K050157

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LPL 2005-04-13

AQUAFLEX 2 (TEFILCON) CONTACT LENS

Applicant Unilens Corp., USA

K number K050743

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LPL 2005-02-02

59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

Applicant Hydrogel Vision Corporation

K number K040303

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LPL 2005-02-01

HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES

Applicant Westcon Contact Lens Co., Inc.

K number K043540

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LPL 2005-01-12

PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)

Applicant Opti-Centre Laboratories

K number K043129

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LPL 2004-11-16

FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

Applicant CooperVision, Inc.

K number K042824

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LPL 2004-10-28

VISTAKON (SENOFILCON A) SOFT CONTACT LENS

Applicant Vistakon

K number K042275

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LPL 2004-10-26

COOPER PROSTHETIC

Applicant CooperVision, Inc.

K number K042435

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LPL 2004-09-15

ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES

Applicant Alden Optical Labs., Inc.

K number K042242

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LPL 2004-07-30

CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR

Applicant Cantor & Nissel , Ltd.

K number K041700

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LPL 2004-07-30

SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

Applicant Soflex Contact Lens Industries , Ltd.

K number K033655

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LPL 2004-07-23

LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS

Applicant CooperVision, Inc.

K number K041138

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LPL 2004-07-07

C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS

Applicant Unilens Corp., USA

K number K041608

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LPL 2004-06-15

S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Optical Connection, Inc.

K number K040900

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LPL 2004-03-12

CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS

Applicant Ciba Vision Corporation

K number K033919

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LPL 2004-03-05

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2

Applicant Innova Vision, Inc.

K number K033136

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LPL 2004-02-20

HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES

Applicant Westcon Contact Lens Co., Inc.

K number K031774

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LPL 2004-02-04

ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

Applicant Vistakon

K number K033969

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LPL 2003-11-07

PROCLEAR COMPATIBLES MULTIFOCAL

Applicant CooperVision, Inc.

K number K032873

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LPL 2003-10-16

VISTAKON (GALYFILCON A) SOFT CONTACT LENS

Applicant Johnson & Johnson Vision Care, Inc.

K number K032340

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LPL 2003-08-29

QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE

Applicant No 7 Contact Lens Laboratory , Ltd.

K number K032256

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LPL 2003-08-01

SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR

Applicant Metro Optics of Austin, Inc.

K number K031532

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LPL 2003-07-18

HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS

Applicant Ocular Sciences, Inc.

K number K031477

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LPL 2003-06-06

ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP

Applicant Soflex Contact Lens Industries , Ltd.

K number K030842

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LPL 2003-05-30

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC

Applicant X-Cel Contacts, A Walman Co.

K number K030593

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LPL 2003-05-14

AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

Applicant Clearlab Pte , Ltd.

K number K030748

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LPL 2003-04-04

SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant St. shine Optical Co., Ltd.

K number K030548

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LPL 2003-04-02

MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

Applicant Clearlab Pte , Ltd.

K number K030167

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LPL 2003-04-01

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

Applicant Gelflex Laboratories

K number K030027

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LPL 2003-02-26

CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

Applicant Contamac, Ltd.

K number K023989

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LPL 2003-02-26

CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

Applicant Contamac, Ltd.

K number K023987

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LPL 2003-02-14

CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

Applicant Contamac, Ltd.

K number K024045

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LPL 2003-02-05

GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT

Applicant Gelflex

K number K024003

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LPL 2003-01-22

ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

Applicant Johnson & Johnson Vision Care, Inc.

K number K024177

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LPL 2003-01-10

NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

Applicant Softfocal Company, Inc.

K number K023791

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LPL 2002-12-24

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

Applicant Contamac, Ltd.

K number K023349

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LPL 2002-12-10

CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Ciba Vision Corporation

K number K023732

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LPL 2002-12-10

OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)

Applicant Ocu-Ease Optical Products, Inc.

K number K023077

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LPL 2002-11-26

HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)

Applicant Westcon Contact Lens Co., Inc.

K number K023530

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LPL 2002-09-04

IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Applicant Igel Vision Care Pte , Ltd.

K number K021907

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LPL 2002-08-12

MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR

Applicant Soflex Isralens Contact Lens , Ltd.

K number K021720

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LPL 2002-06-04

SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

Applicant St. shine Optical Co., Ltd.

K number K021295

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LPL 2002-06-04

IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT

Applicant Igel Vision Care Pte , Ltd.

K number K020855

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LPL 2002-05-24

SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

Applicant Soflex Contact Lens Industries , Ltd.

K number K020642

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LPL 2002-05-16

BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS

Applicant Bausch & Lomb

K number K020927

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LPL 2002-05-16

HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

Applicant Poly Vue Technolgies, Inc.

K number K020608

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LPL 2002-05-06

SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

Applicant St. shine Optical Co., Ltd.

K number K020917

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LPL 2002-04-26

OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS

Applicant Ocu-Ease Optical Products, Inc.

K number K020690

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LPL 2002-04-26

FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR

Applicant CooperVision, Inc.

K number K020392

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LPL 2002-04-09

FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN

Applicant Ciba Vision Corporation

K number K020139

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LPL 2002-02-28

OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

Applicant Cl Mcintosh

K number K020193

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LPL 2002-02-26

ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC

Applicant Vistakon

K number K013973

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LPL 2001-12-26

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

Applicant Sauflon Pharmaceuticals, Ltd.

K number K013649

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LPL 2001-12-26

OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES

Applicant Florida Optical Engineering, Inc.

K number K013445

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LPL 2001-12-20

BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

Applicant Ocular Sciences Puerto Rico, Inc.

K number K013377

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LPL 2001-12-06

COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES

Applicant Contact Color Srl

K number K011893

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LPL 2001-11-20

EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR

Applicant Soflex Contact Lens Industries , Ltd.

K number K013469

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LPL 2001-11-20

TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR

Applicant Soflex Contact Lens Industries , Ltd.

K number K013467

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LPL 2001-11-20

HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

Applicant Poly Vue Technolgies, Inc.

K number K013220

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LPL 2001-10-12

BIOMEDICS UV MULTIFOCAL

Applicant Ocular Sciences Puerto Rico, Inc.

K number K012425

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LPL 2001-08-24

GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS

Applicant Gelflex

K number K011072

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LPL 2001-07-17

TORIC LITE LENS

Applicant Soflex Contact Lens Industries , Ltd.

K number K011256

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LPL 2001-07-09

S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-

Applicant Bescon Co., Ltd.

K number K002099

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LPL 2001-07-09

S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-

Applicant Bescon Co., Ltd.

K number K001962

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LPL 2001-06-26

SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)

Applicant Specialty Ultravision, Inc.

K number K011542

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LPL 2001-06-19

OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

Applicant Ocu-Ease Optical Products, Inc.

K number K011577

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LPL 2001-06-13

BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T

Applicant American Contact Lens, Inc.

K number K011316

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LPL 2001-06-13

BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

Applicant American Biocurve, Inc.

K number K011234

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LPL 2001-05-23

SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

Applicant Specialty Ultravision, Inc.

K number K011089

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LPL 2001-05-23

POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)

Applicant Optech, Inc.

K number K004049

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LPL 2001-04-12

VISTAKON (METHAFILCON A) CONTACT LENSES

Applicant Vistakon

K number K010507

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LPL 2001-04-11

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

Applicant Johnson & Johnson Vision Care, Inc.

K number K010114

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LPL 2001-03-26

ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL

Applicant Opti-Centre Laboratories

K number K010256

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LPL 2001-03-16

BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)

Applicant American Contact Lens, Inc.

K number K010223

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LPL 2001-03-16

VISTAKON (HEFILCON C) CONTACT LENSES

Applicant Vistakon

K number K010218

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LPL 2001-03-12

PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

Applicant Cl-Tinters

K number K010126

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LPL 2001-03-08

BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)

Applicant Benz Research and Development Corp.

K number K003861

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LPL 2001-02-21

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

Applicant Ocu-Ease Optical Products, Inc.

K number K004000

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LPL 2001-02-21

OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

Applicant Ocu-Ease Optical Products, Inc.

K number K003996

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LPL 2001-02-21

SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT

Applicant Specialty Ultravision, Inc.

K number K003789

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LPL 2001-02-13

SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR

Applicant Clearlab Pte , Ltd.

K number K003833

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LPL 2001-02-13

BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE

Applicant American Biocurve, Inc.

K number K001585

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LPL 2001-02-12

SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)

Applicant Specialty Ultravision, Inc.

K number K003526

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LPL 2001-01-22

V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT

Applicant Joe B. Goldberg, O.D.

K number K003042

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LPL 2001-01-06

OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS

Applicant Ocular Sciences Puerto Rico, Inc.

K number K003136

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LPL 2000-12-15

RYTHMIC AND RYTHMIC UV

Applicant Essilor Intl.

K number K003170

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