FDA 510(k) Applications for Medical Device Product Code "HQD"
(Lens, Contact (Other Material) - Daily)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K230910 | Acculens, Inc. | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | 06/16/2023 |
| K162005 | Acuity Polymers, Inc. | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | 12/08/2016 |
| K230965 | Acuity Polymers, Inc. | Acuity 100Ö (hexafocon A) with TangibleÖ Hydra-PEG«, TYROÖ-97 (hofocon A) with TangibleÖ Hydra-PEG« Rigid Gas Permeable Contact Lens | 06/16/2023 |
| K163254 | Acuity Polymers, Inc. | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | 01/18/2017 |
| K180988 | Acuity Polymers, Inc. | 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 | 06/08/2018 |
| K203571 | Acuity Polymers, Inc. | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 04/09/2021 |
| K213538 | Acuity Polymers, Inc. | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 12/30/2021 |
| K201194 | Acuity Polymers, Inc. | Acuity 200Ö (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 09/08/2020 |
| K170007 | Acuity Polymers, Inc. | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | 05/31/2017 |
| K170001 | Acuity Polymers, Inc. | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | 06/02/2017 |
| K152724 | ADVANCED VISION TECHNOLOGIES | EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES | 04/27/2016 |
| K962934 | AIRPERM, INC. | AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR | 08/27/1996 |
| K172314 | Art Optical Contact Lens Inc | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | 09/20/2017 |
| K022128 | BAUSCH & LOMB INCORPORATED | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | 08/22/2002 |
| K053124 | BAUSCH & LOMB INCORPORATED | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | 01/30/2006 |
| K013762 | BAUSCH & LOMB INCORPORATED | RIGID GAS PERMEABLE CONTACT LENS | 04/03/2002 |
| K073184 | BAUSCH & LOMB, INC. | BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS | 02/21/2008 |
| K071266 | BAUSCH & LOMB, INC. | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS | 08/15/2007 |
| K071043 | BAUSCH & LOMB, INC. | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | 08/02/2007 |
| K183167 | Bausch & Lomb, Incorporated | 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 | 02/12/2019 |
| K171404 | BAUSCH + LOMB Incorporated | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | 07/17/2017 |
| K963512 | BENZ RESEARCH AND DEVELOPMENT CORP. | BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL | 07/31/1997 |
| K963744 | BENZ RESEARCH AND DEVELOPMENT CORP. | BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) | 07/31/1997 |
| K153066 | Boston Foundation for Sight | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | 02/09/2016 |
| K161461 | BostonSight | BostonSight PD Prosthetic Device | 07/25/2016 |
| K183175 | BostonSight | BostonSight Scleral | 01/04/2019 |
| K990895 | CONCISE CONTACT LENS CO. | OXYCON LENS | 04/14/1999 |
| K171575 | CONTAMAC Ltd. | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | 10/24/2017 |
| K171077 | CONTAMAC Ltd. | HEXA100 (hexafocon A) Daily Wear Contact Lenses | 08/01/2017 |
| K021977 | CONTAMAC LTD. | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR | 09/12/2002 |
| K182304 | CONTAMAC LTD. | Hyper GP (tisilfocon A) Daily Wear Contact Lens | 11/23/2018 |
| K062548 | CONTAMAC LTD. | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | 11/01/2006 |
| K033594 | CONTAMAC LTD. | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | 03/19/2004 |
| K070628 | CONTAMAC LTD. | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | 05/01/2007 |
| K180616 | Contamac Ltd. | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | 04/25/2018 |
| K161100 | CONTAMAC LTD. | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | 08/10/2016 |
| K081178 | CONTAMAC LTD. | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | 10/09/2008 |
| K212631 | Contamac Ltd. | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | 03/17/2022 |
| K181579 | E&E Optics Inc. | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K | 07/26/2018 |
| K974636 | FUTURISTIC DESIGN ASSOC. | FLOSI RIGID GAS PERMEABLE CONTACT LENS | 03/30/1998 |
| K991780 | G.T. LABORATORIES, INC. | FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C | 06/29/1999 |
| K991781 | G.T. LABORATORIES, INC. | FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS | 06/29/1999 |
| K000485 | INNOVISION, INC. | HYDRO2, HS-75 | 05/12/2000 |
| K011914 | INNOVISION, INC. | HYDRO2, HS-75 | 07/27/2001 |
| K020006 | LENS DYNAMICS, INC. | DYNA INTRA-LIMBAL LENS | 03/29/2002 |
| K021752 | LUCID KOREA CO., LTD | FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL | 10/11/2002 |
| K000233 | MENICON CO. LTD. | MENICON SF-P | 05/19/2000 |
| K103561 | MENICON CO. LTD. | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | 02/03/2011 |
| K962006 | MENICON CO. LTD. | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | 10/09/1996 |
| K081443 | MENICON CO. LTD. | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | 09/23/2008 |
| K972443 | MENICON U.S.A., INC. | MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS | 08/22/1997 |
| K000133 | MENICON U.S.A., INC. | MENICON Z | 05/19/2000 |
| K990264 | METRO OPTICS OF AUSTIN, INC. | COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS | 03/31/1999 |
| K024164 | METRO OPTICS, INC. | COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT | 02/12/2003 |
| K955900 | NOVAVISION, INC. | NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR | 03/25/1996 |
| K960584 | NOVAVISION, INC. | NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY | 08/15/1996 |
| K002703 | OPTICAL POLYMER RESEARCH, INC. | O-PERM 30 | 11/21/2000 |
| K954124 | OPTICAL POLYMER RESEARCH, INC. | O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS | 03/19/1996 |
| K052983 | PARAGON VISION SCIENCES | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | 02/10/2006 |
| K180172 | Paragon Vision Sciences | 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; FluoroP | 03/16/2018 |
| K120996 | PARAGON VISION SCIENCES | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN | 06/28/2012 |
| K070637 | PARAGON VISION SCIENCES | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | 05/01/2007 |
| K082799 | PARAGON VISION SCIENCES | HDS HI 1.54 | 01/27/2009 |
| K002845 | PARAGON VISION SCIENCES | PAFLUFOCON C AND E DAILY CONTACT LENS | 12/08/2000 |
| K013310 | PARAGON VISION SCIENCES | PVS BASIC 2; EPIC 2 | 04/25/2002 |
| K984436 | PARAGON VISION SCIENCES | PVS BASICS | 04/21/1999 |
| K993586 | PARAGON VISION SCIENCES | SPORTSIGHT GP | 05/22/2000 |
| K221768 | Paragon Vision Sciences, Inc. | Oxfore«100 (hexafocon A) Rigid Gas Permeable Contact Lenses | 05/05/2023 |
| K963010 | PERMEABLE TECHNOLOGIES, INC. | LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR | 11/20/1996 |
| K003932 | POLYMER TECHNOLOGY | BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY | 02/16/2001 |
| K000795 | POLYMER TECHNOLOGY | RIGID GAS PERMEABLE CONTACT LENS | 05/26/2000 |
| K001960 | POLYMER TECHNOLOGY | RIGID GAS PERMEABLE CONTACT LENS | 08/28/2000 |
| K002025 | POLYMER TECHNOLOGY | RIGID GAS PERMEABLE CONTACT LENS | 10/31/2000 |
| K970698 | POLYMER TECHNOLOGY CORP. | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | 05/06/1997 |
| K011945 | POLYMER TECHNOLOGY CORP. | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | 09/12/2001 |
| K980741 | POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. | BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) | 05/11/1998 |
| K010454 | PROGRESSIVE OPTICAL RESEARCH LTD. | THE ALBERTA LENS SM2, SULFOCON B | 08/01/2001 |
| K955366 | RAND SCIENTIFIC CORP. | TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS | 03/28/1996 |
| K013646 | ROSE K INTERNATIONAL LTD. | ROSE K POST GRAFT LENS | 05/30/2002 |
| K992787 | SPECIALTY ULTRAVISION, INC. | EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR | 02/02/2000 |
| K980197 | SPECIALTY ULTRAVISION, INC. | ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR | 08/04/1998 |
| K952260 | STELLAR CONTACT LENS, INC. | OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) | 01/03/1996 |
| K051035 | SYNERGEYES | SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS | 09/02/2005 |
| K052675 | SYNERGEYES | SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS | 11/30/2005 |
| K061120 | Synergeyes, Inc. | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES | 06/22/2006 |
| K153714 | Synergeyes, Inc. | 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 (petr | 11/15/2016 |
| K081034 | Synergeyes, Inc. | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS | 05/30/2008 |
| K080193 | Synergeyes, Inc. | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR | 03/05/2008 |
| K060102 | Synergeyes, Inc. | SYNERGEYES PS HYBRID CONTACT LENS | 03/15/2006 |
| K083921 | Synergeyes, Inc. | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS | 05/20/2009 |
| K113586 | Synergeyes, Inc. | SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS | 04/18/2012 |
| K160938 | SynergEyes, Inc. | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens | 08/01/2016 |
| K142510 | Synergeyes, Inc. | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens | 11/19/2014 |
| K033599 | THE LAGADO CORP. | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | 09/16/2004 |
| K052507 | THE LAGADO CORP. | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR | 11/02/2005 |
| K102154 | THE LAGADO CORP. | TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS | 01/21/2011 |
| K213880 | Valley Contax, Inc. | Custom Stable Rigid Gas Permeable Scleral Contact Lens | 01/07/2022 |
| K170335 | Valley Contax, Inc. | Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens | 03/24/2017 |
| K202860 | Valley Contax, Inc. | 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 | 05/11/2021 |
| K223394 | Visionary Optics LLC | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | 12/07/2022 |
| K171950 | Visionary Optics LLC | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) | 08/16/2017 |
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