Lens, Contact (Other Material) - Daily

FDA product code HQD · 117 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.5916
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1984-06-01 – 2026-03-27

HQD 2026-03-27

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Applicant Zhuhai Fitlens Medical Technology Co., Ltd.

K number K253822

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HQD 2024-11-01

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

Applicant Acuity Polymers, Inc.

K number K242393

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HQD 2024-10-22

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

Applicant Tianjin Mastervision Technology Co., Ltd.

K number K241398

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HQD 2024-08-14

BostonSight® Specialty Lenses

Applicant Boston Foundation For Sight, Inc. D/B/A Bostonsight

K number K241571

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HQD 2024-04-03

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K240618

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HQD 2024-02-21

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

Applicant Visionary Optics, LLC

K number K233325

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HQD 2023-06-16

Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K230965

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HQD 2023-06-16

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

Applicant Acculens, Inc.

K number K230910

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HQD 2023-05-05

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

Applicant Paragon Vision Sciences, Inc.

K number K221768

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HQD 2022-12-07

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)

Applicant Visionary Optics, LLC

K number K223394

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HQD 2022-03-17

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

Applicant Contamac, Ltd.

K number K212631

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HQD 2022-01-07

Custom Stable Rigid Gas Permeable Scleral Contact Lens

Applicant Valley Contax, Inc.

K number K213880

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HQD 2021-12-30

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K213538

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HQD 2021-05-11

Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

Applicant Valley Contax, Inc.

K number K202860

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HQD 2021-04-09

Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K203571

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HQD 2020-09-08

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K201194

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HQD 2019-02-12

Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens

Applicant Bausch & Lomb, Incorporated

K number K183167

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HQD 2019-01-04

BostonSight Scleral

Applicant Bostonsight

K number K183175

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HQD 2018-11-23

Hyper GP (tisilfocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K number K182304

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HQD 2018-07-26

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

Applicant E&E Optics, Inc.

K number K181579

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HQD 2018-06-08

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K180988

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HQD 2018-04-25

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K number K180616

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HQD 2018-03-16

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

Applicant Paragon Vision Sciences

K number K180172

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HQD 2017-10-24

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

Applicant Contamac, Ltd.

K number K171575

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HQD 2017-09-20

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

Applicant Art Optical Contact Lens, Inc.

K number K172314

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HQD 2017-08-16

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)

Applicant Visionary Optics, LLC

K number K171950

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HQD 2017-08-01

HEXA100 (hexafocon A) Daily Wear Contact Lenses

Applicant Contamac, Ltd.

K number K171077

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HQD 2017-07-17

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

Applicant Bausch + Lomb, Incorporated

K number K171404

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HQD 2017-06-02

Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K170001

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HQD 2017-05-31

Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K170007

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HQD 2017-03-24

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens

Applicant Valley Contax, Inc.

K number K170335

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HQD 2017-01-18

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K163254

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HQD 2016-12-08

Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K number K162005

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HQD 2016-11-15

SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co

Applicant Synergeyes, Inc.

K number K153714

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HQD 2016-08-10

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

Applicant Contamac, Ltd.

K number K161100

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HQD 2016-08-01

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

Applicant Synergeyes, Inc.

K number K160938

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HQD 2016-07-25

BostonSight PD Prosthetic Device

Applicant Bostonsight

K number K161461

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HQD 2016-04-27

EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES

Applicant Advanced Vision Technologies

K number K152724

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HQD 2016-02-09

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

Applicant Boston Foundation For Sight

K number K153066

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HQD 2012-06-28

FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN

Applicant Paragon Vision Sciences

K number K120996

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HQD 2012-04-18

SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS

Applicant Synergeyes, Inc.

K number K113586

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HQD 2011-02-03

MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Applicant Menicon Co, Ltd.

K number K103561

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HQD 2011-01-21

TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

Applicant The Lagado Corp.

K number K102154

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HQD 2009-05-20

SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS

Applicant Synergeyes, Inc.

K number K083921

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HQD 2009-01-27

HDS HI 1.54

Applicant Paragon Vision Sciences

K number K082799

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HQD 2008-10-09

OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

Applicant Contamac, Ltd.

K number K081178

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HQD 2008-09-23

MENICON Z RIGID GAS PERMEABLE CONTACT LENS

Applicant Menicon Co, Ltd.

K number K081443

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HQD 2008-05-30

SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS

Applicant Synergeyes, Inc.

K number K081034

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HQD 2008-03-05

SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR

Applicant Synergeyes, Inc.

K number K080193

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HQD 2008-02-21

BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS

Applicant Bausch & Lomb, Inc.

K number K073184

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HQD 2007-08-15

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS

Applicant Bausch & Lomb, Inc.

K number K071266

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HQD 2007-08-02

BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES

Applicant Bausch & Lomb, Inc.

K number K071043

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HQD 2007-05-01

FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES

Applicant Paragon Vision Sciences

K number K070637

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HQD 2007-05-01

OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.

Applicant Contamac, Ltd.

K number K070628

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HQD 2006-11-01

MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

Applicant Contamac, Ltd.

K number K062548

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HQD 2006-06-22

SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES

Applicant Synergeyes, Inc.

K number K061120

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HQD 2006-03-15

SYNERGEYES PS HYBRID CONTACT LENS

Applicant Synergeyes, Inc.

K number K060102

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HQD 2006-02-10

FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES

Applicant Paragon Vision Sciences

K number K052983

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HQD 2006-01-30

BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES

Applicant Bausch & Lomb, Incorporated

K number K053124

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HQD 2005-11-30

SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

Applicant Synergeyes

K number K052675

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HQD 2005-11-02

TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR

Applicant The Lagado Corp.

K number K052507

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HQD 2005-09-02

SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

Applicant Synergeyes

K number K051035

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HQD 2004-09-16

ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

Applicant The Lagado Corp.

K number K033599

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HQD 2004-03-19

OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

Applicant Contamac, Ltd.

K number K033594

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HQD 2003-02-12

COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT

Applicant Metro Optics, Inc.

K number K024164

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HQD 2002-10-11

FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

Applicant Lucid Korea Co., Ltd.

K number K021752

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HQD 2002-09-12

HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

Applicant Contamac, Ltd.

K number K021977

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HQD 2002-08-22

BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Applicant Bausch & Lomb, Incorporated

K number K022128

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HQD 2002-05-30

ROSE K POST GRAFT LENS

Applicant Rose K International , Ltd.

K number K013646

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HQD 2002-04-25

PVS BASIC 2; EPIC 2

Applicant Paragon Vision Sciences

K number K013310

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HQD 2002-04-03

RIGID GAS PERMEABLE CONTACT LENS

Applicant Bausch & Lomb, Incorporated

K number K013762

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HQD 2002-03-29

DYNA INTRA-LIMBAL LENS

Applicant Lens Dynamics, Inc.

K number K020006

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HQD 2001-09-12

RIGID GAS PERMEABLE CONTACT LENS SOLUTION

Applicant Polymer Technology Corp.

K number K011945

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HQD 2001-08-01

THE ALBERTA LENS SM2, SULFOCON B

Applicant Progressive Optical Research , Ltd.

K number K010454

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HQD 2001-07-27

HYDRO2, HS-75

Applicant Innovision, Inc.

K number K011914

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HQD 2001-02-16

BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY

Applicant Polymer Technology

K number K003932

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HQD 2000-12-08

PAFLUFOCON C AND E DAILY CONTACT LENS

Applicant Paragon Vision Sciences

K number K002845

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HQD 2000-11-21

O-PERM 30

Applicant Optical Polymer Research, Inc.

K number K002703

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HQD 2000-10-31

RIGID GAS PERMEABLE CONTACT LENS

Applicant Polymer Technology

K number K002025

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HQD 2000-08-28

RIGID GAS PERMEABLE CONTACT LENS

Applicant Polymer Technology

K number K001960

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HQD 2000-05-26

RIGID GAS PERMEABLE CONTACT LENS

Applicant Polymer Technology

K number K000795

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HQD 2000-05-22

SPORTSIGHT GP

Applicant Paragon Vision Sciences

K number K993586

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HQD 2000-05-19

MENICON SF-P

Applicant Menicon Co, Ltd.

K number K000233

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HQD 2000-05-19

MENICON Z

Applicant Menicon U.S.A., Inc.

K number K000133

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HQD 2000-05-12

HYDRO2, HS-75

Applicant Innovision, Inc.

K number K000485

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HQD 2000-02-02

EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR

Applicant Specialty Ultravision, Inc.

K number K992787

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HQD 1999-06-29

FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS

Applicant G.T. Laboratories, Inc.

K number K991781

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HQD 1999-06-29

FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C

Applicant G.T. Laboratories, Inc.

K number K991780

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HQD 1999-04-21

PVS BASICS

Applicant Paragon Vision Sciences

K number K984436

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HQD 1999-04-14

OXYCON LENS

Applicant Concise Contact Lens Co.

K number K990895

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HQD 1999-03-31

COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS

Applicant Metro Optics of Austin, Inc.

K number K990264

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HQD 1998-08-04

ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR

Applicant Specialty Ultravision, Inc.

K number K980197

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HQD 1998-05-11

BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)

Applicant Polymer Technology Div. Wilmington Partners, L.P.

K number K980741

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HQD 1998-03-30

FLOSI RIGID GAS PERMEABLE CONTACT LENS

Applicant Futuristic Design Assoc.

K number K974636

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HQD 1997-08-22

MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS

Applicant Menicon U.S.A., Inc.

K number K972443

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HQD 1997-07-31

BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)

Applicant Benz Research and Development Corp.

K number K963744

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HQD 1997-07-31

BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

Applicant Benz Research and Development Corp.

K number K963512

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HQD 1997-05-06

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS

Applicant Polymer Technology Corp.

K number K970698

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HQD 1996-11-20

LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR

Applicant Permeable Technologies, Inc.

K number K963010

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HQD 1996-10-09

MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Applicant Menicon Co, Ltd.

K number K962006

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