Ophthalmic

HQD · Lens, Contact (Other Material) - Daily

Ophthalmic · 21 CFR 886.5916 · Class 2

Overview

Product CodeHQD
Device NameLens, Contact (Other Material) - Daily
Regulation21 CFR 886.5916
Device ClassClass 2
Review PanelOphthalmic
3rd-Party ReviewableYes

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Classification Rationale

(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.

Cleared Devices (120)

RecordDevice NameApplicantDecision DateDecision
K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.Mar 27, 2026SESE
K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.Nov 1, 2024SESE
K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.Oct 22, 2024SESE
K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightAug 14, 2024SESE
K240618Acuity 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 LensAcuity Polymers, Inc.Apr 3, 2024SESE
K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLCFeb 21, 2024SESE
K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Jun 16, 2023SESE
K230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral LensAcculens, Inc.Jun 16, 2023SESE
K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesParagon Vision Sciences, Inc.May 5, 2023SESE
K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)Visionary Optics, LLCDec 7, 2022SESE
K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.Mar 17, 2022SESE
K213880Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.Jan 7, 2022SESE
K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Dec 30, 2021SESE
K202860Valley 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)Valley Contax, Inc.May 11, 2021SESE
K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Apr 9, 2021SESE
K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Sep 8, 2020SESE
K183167Boston 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 LensBausch & Lomb, IncorporatedFeb 12, 2019SESE
K183175BostonSight ScleralBostonsightJan 4, 2019SESE
K182304Hyper GP (tisilfocon A) Daily Wear Contact LensContamac, Ltd.Nov 23, 2018SESE
K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-KE&E Optics, Inc.Jul 26, 2018SESE
K180988Acuity 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 LensAcuity Polymers, Inc.Jun 8, 2018SESE
K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensContamac, Ltd.Apr 25, 2018SESE
K180172FluoroPerm 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-PEGParagon Vision SciencesMar 16, 2018SESE
K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.Oct 24, 2017SESE
K172314Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)Art Optical Contact Lens, Inc.Sep 20, 2017SESE
K171950Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)Visionary Optics, LLCAug 16, 2017SESE
K171077HEXA100 (hexafocon A) Daily Wear Contact LensesContamac, Ltd.Aug 1, 2017SESE
K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, IncorporatedJul 17, 2017SESE
K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Jun 2, 2017SESE
K170007Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.May 31, 2017SESE
K170335Custom Stable(TM) Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.Mar 24, 2017SESE
K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Jan 18, 2017SESE
K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.Dec 8, 2016SESE
K153714SynergEyes 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 CoSynergeyes, Inc.Nov 15, 2016SESE
K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.Aug 10, 2016SESE
K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.Aug 1, 2016SESE
K161461BostonSight PD Prosthetic DeviceBostonsightJul 25, 2016SESE
K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision TechnologiesApr 27, 2016SESE
K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For SightFeb 9, 2016SESE
K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact LensSynergeyes, Inc.Nov 19, 2014SESE
K120996FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THINParagon Vision SciencesJun 28, 2012SESE
K113586SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENSSynergeyes, Inc.Apr 18, 2012SESE
K103561MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.Feb 3, 2011SESE
K102154TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSThe Lagado Corp.Jan 21, 2011SESE
K083921SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENSSynergeyes, Inc.May 20, 2009SESE
K082799HDS HI 1.54Paragon Vision SciencesJan 27, 2009SESE
K081178OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSESContamac, Ltd.Oct 9, 2008SESE
K081443MENICON Z RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.Sep 23, 2008SESE
K081034SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PSSynergeyes, Inc.May 30, 2008SESE
K080193SYNERGEYES HYBRID CONTACT LENSES-DAILY WEARSynergeyes, Inc.Mar 5, 2008SESE
K073184BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYSBausch & Lomb, Inc.Feb 21, 2008SESE
K071266BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENSBausch & Lomb, Inc.Aug 15, 2007SESE
K071043BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSESBausch & Lomb, Inc.Aug 2, 2007SESE
K070637FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSESParagon Vision SciencesMay 1, 2007SESE
K070628OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.Contamac, Ltd.May 1, 2007SESE
K062548MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESContamac, Ltd.Nov 1, 2006SESE
K061120SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSESSynergeyes, Inc.Jun 22, 2006SESE
K060102SYNERGEYES PS HYBRID CONTACT LENSSynergeyes, Inc.Mar 15, 2006SESE
K052983FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSESParagon Vision SciencesFeb 10, 2006SESE
K053124BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSESBausch & Lomb, IncorporatedJan 30, 2006SESE
K052675SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUSSynergeyesNov 30, 2005SESE
K052507TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEARThe Lagado Corp.Nov 2, 2005SESE
K051035SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENSSynergeyesSep 2, 2005SESE
K033599ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSThe Lagado Corp.Sep 16, 2004SESE
K033594OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESContamac, Ltd.Mar 19, 2004SESE
K024164COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACTMetro Optics, Inc.Feb 12, 2003SESE
K021752FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICALLucid Korea Co., Ltd.Oct 11, 2002SESE
K021977HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEARContamac, Ltd.Sep 12, 2002SESE
K022128BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENSBausch & Lomb, IncorporatedAug 22, 2002SESE
K013646ROSE K POST GRAFT LENSRose K International , Ltd.May 30, 2002SESE
K013310PVS BASIC 2; EPIC 2Paragon Vision SciencesApr 25, 2002SESE
K013762RIGID GAS PERMEABLE CONTACT LENSBausch & Lomb, IncorporatedApr 3, 2002SESE
K020006DYNA INTRA-LIMBAL LENSLens Dynamics, Inc.Mar 29, 2002SESE
K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTIONPolymer Technology Corp.Sep 12, 2001SESE
K010454THE ALBERTA LENS SM2, SULFOCON BProgressive Optical Research , Ltd.Aug 1, 2001SESE
K011914HYDRO2, HS-75Innovision, Inc.Jul 27, 2001SESE
K003932BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGYPolymer TechnologyFeb 16, 2001SESE
K002845PAFLUFOCON C AND E DAILY CONTACT LENSParagon Vision SciencesDec 8, 2000SESE
K002703O-PERM 30Optical Polymer Research, Inc.Nov 21, 2000SESE
K002025RIGID GAS PERMEABLE CONTACT LENSPolymer TechnologyOct 31, 2000SESE
K001960RIGID GAS PERMEABLE CONTACT LENSPolymer TechnologyAug 28, 2000SESE
K000795RIGID GAS PERMEABLE CONTACT LENSPolymer TechnologyMay 26, 2000SESE
K993586SPORTSIGHT GPParagon Vision SciencesMay 22, 2000SESE
K000233MENICON SF-PMenicon Co, Ltd.May 19, 2000SESE
K000133MENICON ZMenicon U.S.A., Inc.May 19, 2000SESE
K000485HYDRO2, HS-75Innovision, Inc.May 12, 2000SESE
K992787EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEARSpecialty Ultravision, Inc.Feb 2, 2000SESE
K991781FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENSG.T. Laboratories, Inc.Jun 29, 1999SESE
K991780FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE CG.T. Laboratories, Inc.Jun 29, 1999SESE
K984436PVS BASICSParagon Vision SciencesApr 21, 1999SESE
K990895OXYCON LENSConcise Contact Lens Co.Apr 14, 1999SESE
K990264COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENSMetro Optics of Austin, Inc.Mar 31, 1999SESE
K980197ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEARSpecialty Ultravision, Inc.Aug 4, 1998SESE
K980741BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)Polymer Technology Div. Wilmington Partners, L.P.May 11, 1998SESE
K974636FLOSI RIGID GAS PERMEABLE CONTACT LENSFuturistic Design Assoc.Mar 30, 1998SESE
K972443MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENSMenicon U.S.A., Inc.Aug 22, 1997SESE
K963744BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)Benz Research and Development Corp.Jul 31, 1997SESE
K963512BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BLBenz Research and Development Corp.Jul 31, 1997SESE
K970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENSPolymer Technology Corp.May 6, 1997SESE
K963010LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEARPermeable Technologies, Inc.Nov 20, 1996SESE
K962006MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.Oct 9, 1996SESE
K962934AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEARAirperm, Inc.Aug 27, 1996SESE
K960584NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLYNovavision, Inc.Aug 15, 1996SESE
K955366TRANS-AIRE RIGID GAS PERMABLE CONTACT LENSRand Scientific Corp.Mar 28, 1996SESE
K955900NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LRNovavision, Inc.Mar 25, 1996SESE
K954124O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENSOptical Polymer Research, Inc.Mar 19, 1996SESE
K952260OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)Stellar Contact Lens, Inc.Jan 3, 1996SESE
K952165TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENSRand Scientific Corp.Jun 30, 1995SESE
K945955ROSE K LENSRose K International , Ltd.Feb 7, 1995SESE
K944223ACCUCONInnovision, Inc.Dec 7, 1994SESE
K941883CONTACT LENSAirperm, Inc.Oct 28, 1994SESE
K943784MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEARMenicon Co, Ltd.Oct 20, 1994SESE
K943177BOSTON(R) 7 - 30(ENFLUFOCON A)Polymer Technology Corp.Aug 25, 1994SESE
K942533NOVALENS/NOVAWET PERCEPTION AND VANGUARDOcutec Corporation, Inc.Aug 5, 1994SESE
K942365BOSTON VIIPolymer Technology Corp.Jun 23, 1994SESE
K940277PAFLUFOCON A, B, C & DParagon Vision SciencesMay 9, 1994SESE
P840050OCUSIL(TM) CONTACT LENSO.S.I. Corp.Nov 20, 1985APRL
K841163CONTACT LENS INSERTER/REMOVEROptimum Manufacturers, Inc.Jun 1, 1984SESE
K840115SWISS OPTICAL PRODUCTS-CONTACT CASEMoonbeam International, Inc.Jun 1, 1984SESE
P790010DANKER SILICONE LENS (DIMEFOCON-A)Ciba Vision CorporationMay 28, 1982APWD

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