Atlas FDA

HQD

118 FDA 510(k) clearances · Product code

88 daysmedian time to decision
203 days90th percentile
118clearances measured

FDA profile

Official device name
Lens, Contact (Other Material) - Daily
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5916
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2008: 8 · 2009: 12 · 2011: 7 · 2012: 10 · 2013: 15 · 2014: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (K253822)Zhuhai Fitlens Medical Technology Co., Ltd.2026-03-27
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393)Acuity Polymers, Inc.2024-11-01
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398)Tianjin Mastervision Technology Co., Ltd.2024-10-22
BostonSight® Specialty Lenses (K241571)Boston Foundation For Sight, Inc. D/B/A Bostonsight2024-08-14
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 (K240618)Acuity Polymers, Inc.2024-04-03
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (K233325)Visionary Optics, LLC2024-02-21
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens (K230910)Acculens, Inc.2023-06-16
Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (K230965)Acuity Polymers, Inc.2023-06-16
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768)Paragon Vision Sciences, Inc.2023-05-05
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (K223394)Visionary Optics, LLC2022-12-07
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631)Contamac, Ltd.2022-03-17
Custom Stable Rigid Gas Permeable Scleral Contact Lens (K213880)Valley Contax, Inc.2022-01-07
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K213538)Acuity Polymers, Inc.2021-12-30
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) (K202860)Valley Contax, Inc.2021-05-11
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571)Acuity Polymers, Inc.2021-04-09
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194)Acuity Polymers, Inc.2020-09-08
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 (K183167)Bausch & Lomb, Incorporated2019-02-12
BostonSight Scleral (K183175)Bostonsight2019-01-04
Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304)Contamac, Ltd.2018-11-23
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K (K181579)E&E Optics, Inc.2018-07-26
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 (K180988)Acuity Polymers, Inc.2018-06-08
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616)Contamac, Ltd.2018-04-25
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 (K180172)Paragon Vision Sciences2018-03-16
ENFLU 18 (enflufocon A) Daily Wear Contact Lens (K171575)Contamac, Ltd.2017-10-24
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) (K172314)Art Optical Contact Lens, Inc.2017-09-20
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) (K171950)Visionary Optics, LLC2017-08-16
HEXA100 (hexafocon A) Daily Wear Contact Lenses (K171077)Contamac, Ltd.2017-08-01
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (K171404)Bausch + Lomb, Incorporated2017-07-17
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens (K170001)Acuity Polymers, Inc.2017-06-02
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens (K170007)Acuity Polymers, Inc.2017-05-31
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens (K170335)Valley Contax, Inc.2017-03-24
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens (K163254)Acuity Polymers, Inc.2017-01-18
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K162005)Acuity Polymers, Inc.2016-12-08
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 (K153714)Synergeyes, Inc.2016-11-15
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (K161100)Contamac, Ltd.2016-08-10
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (K160938)Synergeyes, Inc.2016-08-01
BostonSight PD Prosthetic Device (K161461)Bostonsight2016-07-25
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES (K152724)Advanced Vision Technologies2016-04-27
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (K153066)Boston Foundation For Sight2016-02-09
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens (K142510)Synergeyes, Inc.2014-11-19
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN (K120996)Paragon Vision Sciences2012-06-28
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K113586)Synergeyes, Inc.2012-04-18
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K103561)Menicon Co, Ltd.2011-02-03
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K102154)The Lagado Corp.2011-01-21
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K083921)Synergeyes, Inc.2009-05-20
HDS HI 1.54 (K082799)Paragon Vision Sciences2009-01-27
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES (K081178)Contamac, Ltd.2008-10-09
MENICON Z RIGID GAS PERMEABLE CONTACT LENS (K081443)Menicon Co, Ltd.2008-09-23
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS (K081034)Synergeyes, Inc.2008-05-30
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR (K080193)Synergeyes, Inc.2008-03-05
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS (K073184)Bausch & Lomb, Inc.2008-02-21
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS (K071266)Bausch & Lomb, Inc.2007-08-15
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES (K071043)Bausch & Lomb, Inc.2007-08-02
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES (K070637)Paragon Vision Sciences2007-05-01
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. (K070628)Contamac, Ltd.2007-05-01
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K062548)Contamac, Ltd.2006-11-01
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES (K061120)Synergeyes, Inc.2006-06-22
SYNERGEYES PS HYBRID CONTACT LENS (K060102)Synergeyes, Inc.2006-03-15
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES (K052983)Paragon Vision Sciences2006-02-10
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES (K053124)Bausch & Lomb, Incorporated2006-01-30
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS (K052675)Synergeyes2005-11-30
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR (K052507)The Lagado Corp.2005-11-02
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS (K051035)Synergeyes2005-09-02
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K033599)The Lagado Corp.2004-09-16
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K033594)Contamac, Ltd.2004-03-19
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT (K024164)Metro Optics, Inc.2003-02-12
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL (K021752)Lucid Korea Co., Ltd.2002-10-11
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR (K021977)Contamac, Ltd.2002-09-12
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K022128)Bausch & Lomb, Incorporated2002-08-22
ROSE K POST GRAFT LENS (K013646)Rose K International , Ltd.2002-05-30
PVS BASIC 2; EPIC 2 (K013310)Paragon Vision Sciences2002-04-25
RIGID GAS PERMEABLE CONTACT LENS (K013762)Bausch & Lomb, Incorporated2002-04-03
DYNA INTRA-LIMBAL LENS (K020006)Lens Dynamics, Inc.2002-03-29
RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K011945)Polymer Technology Corp.2001-09-12
THE ALBERTA LENS SM2, SULFOCON B (K010454)Progressive Optical Research , Ltd.2001-08-01
HYDRO2, HS-75 (K011914)Innovision, Inc.2001-07-27
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (K003932)Polymer Technology2001-02-16
PAFLUFOCON C AND E DAILY CONTACT LENS (K002845)Paragon Vision Sciences2000-12-08
O-PERM 30 (K002703)Optical Polymer Research, Inc.2000-11-21
RIGID GAS PERMEABLE CONTACT LENS (K002025)Polymer Technology2000-10-31
RIGID GAS PERMEABLE CONTACT LENS (K001960)Polymer Technology2000-08-28
RIGID GAS PERMEABLE CONTACT LENS (K000795)Polymer Technology2000-05-26
SPORTSIGHT GP (K993586)Paragon Vision Sciences2000-05-22
MENICON SF-P (K000233)Menicon Co, Ltd.2000-05-19
MENICON Z (K000133)Menicon U.S.A., Inc.2000-05-19
HYDRO2, HS-75 (K000485)Innovision, Inc.2000-05-12
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR (K992787)Specialty Ultravision, Inc.2000-02-02
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS (K991781)G.T. Laboratories, Inc.1999-06-29
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C (K991780)G.T. Laboratories, Inc.1999-06-29
PVS BASICS (K984436)Paragon Vision Sciences1999-04-21
OXYCON LENS (K990895)Concise Contact Lens Co.1999-04-14
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS (K990264)Metro Optics of Austin, Inc.1999-03-31
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR (K980197)Specialty Ultravision, Inc.1998-08-04
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) (K980741)Polymer Technology Div. Wilmington Partners, L.P.1998-05-11
FLOSI RIGID GAS PERMEABLE CONTACT LENS (K974636)Futuristic Design Assoc.1998-03-30
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS (K972443)Menicon U.S.A., Inc.1997-08-22
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) (K963744)Benz Research and Development Corp.1997-07-31
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL (K963512)Benz Research and Development Corp.1997-07-31
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (K970698)Polymer Technology Corp.1997-05-06
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K963010)Permeable Technologies, Inc.1996-11-20
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