Lenses, Soft Contact, Daily Wear
Daily wear soft contact lenses are hydrophilic lenses worn on the cornea of the eye during waking hours to correct refractive errors such as myopia, hyperopia, or astigmatism, and must be removed before sleeping. They are classified as a Class 2 (moderate risk) device, subject to general and special controls, and require 510(k) premarket notification before marketing. The product code is LPL, regulated under 21 CFR 886.5925, within the Ophthalmic medical specialty. This device is eligible for third-party review as part of the FDA's accredited persons program.
Basic Information
- Product Code
- LPL
- Device Class
- FDA class 2
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 473 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Jul 02, 2025 | Substantially Equivalent | Pegavision Corporation |
| K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Apr 17, 2025 | Substantially Equivalent | BenQ Materials Corporation |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Apr 10, 2025 | Substantially Equivalent | VizionFocus Inc. |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Mar 20, 2025 | Substantially Equivalent | Hunan Haipuming Technology Co., Ltd. |
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Feb 04, 2025 | Substantially Equivalent | Largan Medical Co., Ltd. |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Jan 13, 2025 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Dec 17, 2024 | Substantially Equivalent | VizionFocus Inc. |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Dec 16, 2024 | Substantially Equivalent | Yung Sheng Optical Co., Ltd. |
| K240918 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism | Oct 25, 2024 | Substantially Equivalent | Bruno Vision Care, LLC |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Oct 08, 2024 | Substantially Equivalent | LUCENS TECHNOLOGY Co., Ltd. |
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | Aug 14, 2024 | Substantially Equivalent | X-Cel Specialty Contacts, A Walman Optical Company |
| K241707 | OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL | Jul 12, 2024 | Substantially Equivalent | Unicon Optical Co., Ltd. |
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | Jul 01, 2024 | Substantially Equivalent | St. shine Optical Co., Ltd. |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | May 08, 2024 | Substantially Equivalent | Pegavision Corporation |
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Apr 17, 2024 | Substantially Equivalent | Innova Vision Inc. |
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Feb 06, 2024 | Substantially Equivalent | Metro Optics of Austin, Inc. |
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | Jan 25, 2024 | Substantially Equivalent | CooperVision, Inc. |
| K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Jan 03, 2024 | Substantially Equivalent | HOYA Lamphun Ltd. |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Dec 29, 2023 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear | Dec 20, 2023 | Substantially Equivalent | Yung Sheng Optical Co., Ltd. |
| K230954 | Samfilcon B Custom Contact Lens | Nov 17, 2023 | Substantially Equivalent | Bausch + Lomb, Incorporated |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Nov 16, 2023 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Nov 16, 2023 | Substantially Equivalent | Innova Vision Inc. |
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Sep 06, 2023 | Substantially Equivalent | Art Optical Contact Lens, Inc. |
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | May 31, 2023 | Substantially Equivalent | Pegavision Corporation |
| K230785 | Precision1, Precision1 for Astigmatism | Apr 20, 2023 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | Mar 13, 2023 | Substantially Equivalent | Innova Vision Inc. |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Mar 08, 2023 | Substantially Equivalent | Bausch & Lomb Incorporated |
| K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens | Oct 04, 2022 | Substantially Equivalent | Interojo Inc. |
| K222500 | AIR OPTIX COLORS | Sep 15, 2022 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K220143 | BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | Sep 08, 2022 | Substantially Equivalent | Shenzhen Dashicheng Optical Technology Co., Ltd. |
| K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear | Sep 02, 2022 | Substantially Equivalent | Yung Sheng Optical Co., Ltd |
| K220045 | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | Aug 05, 2022 | Substantially Equivalent | DK Medivision Co., Ltd. |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | May 13, 2022 | Substantially Equivalent | Innova Vision Inc. |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | Feb 04, 2022 | Substantially Equivalent | CooperVision, Inc. |
| K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Feb 02, 2022 | Substantially Equivalent | Pegavision Corporation |
| K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | Jan 18, 2022 | Substantially Equivalent | Unicon Optical Co., Ltd |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | Dec 28, 2021 | Substantially Equivalent | Alcon Laboratories, Inc |
| K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Dec 06, 2021 | Substantially Equivalent | Pegavision Corporation |
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | Nov 29, 2021 | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. |
| K213164 | Avaira Vitality | Oct 26, 2021 | Substantially Equivalent | CooperVision. Inc. |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | May 24, 2021 | Substantially Equivalent | Bausch & Lomb Incorporated |
| K210609 | AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens | Apr 27, 2021 | Substantially Equivalent | VP Optics |
| K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | Apr 12, 2021 | Substantially Equivalent | Alcon Laboratories Inc. |
| K202129 | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo | Apr 01, 2021 | Substantially Equivalent | Largan Medical Co., Ltd. |
| K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | Dec 07, 2020 | Substantially Equivalent | Visco Vision Inc |
| K201268 | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Oct 21, 2020 | Substantially Equivalent | Plexus Optix, Inc. |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | Oct 20, 2020 | Substantially Equivalent | CooperVision, Inc. |
| K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | Oct 15, 2020 | Substantially Equivalent | Pegavision Corporation |
| K201013 | Optixon 1-Day | Sep 18, 2020 | Substantially Equivalent | Optixon Inc. |
| K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens | Jul 15, 2020 | Substantially Equivalent | Visco Vision Inc |
| K193399 | Miru 1day UpSide (midafilcon A) | Jun 17, 2020 | Substantially Equivalent | Menicon Co., Ltd. |
| K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | Jun 02, 2020 | Substantially Equivalent | Bausch + Lomb, Incorporated |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | Mar 23, 2020 | Substantially Equivalent | CooperVision, Inc. |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Mar 17, 2020 | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. |
| K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | Dec 09, 2019 | Substantially Equivalent | VizionFocus, Inc. |
| K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | Oct 02, 2019 | Substantially Equivalent | Visco Vision Inc. |
| K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens | Sep 27, 2019 | Substantially Equivalent | Clearlab SG Pte, Ltd |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Sep 17, 2019 | Substantially Equivalent | UNICON Optical CO., LTD |
| K183670 | Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens | Sep 13, 2019 | Substantially Equivalent | Visco Vision Inc |
| K191121 | Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens | Sep 06, 2019 | Substantially Equivalent | Lentechs, LLC |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | May 16, 2019 | Substantially Equivalent | UNICON Optical CO., LTD |
| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent | CooperVision, Inc. |
| K181656 | ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) | Mar 05, 2019 | Substantially Equivalent | Eyemed Technologies S.r.l. |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | Feb 06, 2019 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | Jan 18, 2019 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K182902 | Precision1 | Dec 11, 2018 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent | CooperVision, Inc. |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Nov 30, 2018 | Substantially Equivalent | Bausch & Lomb Incorporated |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal | Nov 21, 2018 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Nov 13, 2018 | Substantially Equivalent | Largan Medical Co., Ltd |
| K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Nov 01, 2018 | Substantially Equivalent | Largan Medical Co., Ltd. |
| K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) | Oct 12, 2018 | Substantially Equivalent | VizionFocus, Inc. |
| K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | Sep 19, 2018 | Substantially Equivalent | Visco Vision Inc |
| K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | Sep 06, 2018 | Substantially Equivalent | Gelflex Laboratories |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | Aug 03, 2018 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Jun 29, 2018 | Substantially Equivalent | Largan Medical Co. Ltd. |
| K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA | Jun 25, 2018 | Substantially Equivalent | Largan Medical Co. Ltd. |
| K181050 | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Jun 13, 2018 | Substantially Equivalent | Qualimed SRL |
| K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Jun 08, 2018 | Substantially Equivalent | Supervision Optimax SDN BHD |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | May 16, 2018 | Substantially Equivalent | Menicon Co., Ltd. |
| K180669 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal | Apr 27, 2018 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Apr 20, 2018 | Substantially Equivalent | Visco Vision Inc. |
| K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal | Apr 10, 2018 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | Apr 10, 2018 | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. |
| K173958 | OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens | Apr 03, 2018 | Substantially Equivalent | Visco Vision Inc |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Feb 22, 2018 | Substantially Equivalent | Menicon Co., Ltd. |
| K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens | Dec 13, 2017 | Substantially Equivalent | Tangible Science LLC |
| K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | Dec 05, 2017 | Substantially Equivalent | Visco Vision Inc |
| K173086 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Nov 07, 2017 | Substantially Equivalent | Visioneering Technologies, Inc. |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | Oct 25, 2017 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K171125 | Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | Oct 18, 2017 | Substantially Equivalent | Tangible Science LLC |
| K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA | Sep 18, 2017 | Substantially Equivalent | Largan Medical Co. Ltd. |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Aug 09, 2017 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K171157 | PolyDev Soft Contact Lenses | Jun 02, 2017 | Substantially Equivalent | Polydev Ltd. |
| K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Jan 04, 2017 | Substantially Equivalent | SUPERVISION OPTIMAX SDN BHD |
| K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Dec 19, 2016 | Substantially Equivalent | PEGAVISION CORPORATION |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Nov 30, 2016 | Substantially Equivalent | ALCON LABORATORIES, INC. |
| K160245 | Visco (olifilcon A) soft contact lens | Oct 24, 2016 | Substantially Equivalent | Visco Vision Inc |
| K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens | Oct 21, 2016 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K162596 | AIR OPTIX COLORS | Oct 13, 2016 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K161931 | Toricolors (hioxifilcon D) Soft Contact Lenses | Oct 12, 2016 | Substantially Equivalent | POLYDEV LTD. |
| K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | Aug 26, 2016 | Substantially Equivalent | VISION SCIENCE CO.,LTD. |
| K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | Aug 22, 2016 | Substantially Equivalent | JOOWON INNOVATION CO., LTD. |
| K160472 | Hidrocor, Hidrocharme, and Natural Colors | Aug 10, 2016 | Substantially Equivalent | SOLOTICA |
| K160977 | PolyDev Soft Contact Lenses | Jul 13, 2016 | Substantially Equivalent | Polydev Ltd. |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent | CooperVision, Inc. |
| K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 | May 26, 2016 | Substantially Equivalent | Visco Vision Inc |
| K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | May 17, 2016 | Substantially Equivalent | SMART PERFORMER CORP. LTD. |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric | May 02, 2016 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear | Apr 08, 2016 | Substantially Equivalent | Interojo Inc. |
| K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear | Apr 08, 2016 | Substantially Equivalent | EYEYON MEDICAL |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Mar 28, 2016 | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. |
| K151847 | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | Mar 04, 2016 | Substantially Equivalent | SMART PERFORMER CORP. LTD. |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | Feb 11, 2016 | Substantially Equivalent | BAUSCH & LOMB INCORPORATED |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Jan 20, 2016 | Substantially Equivalent | ALCON LABORATORIES, INC. |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Jan 20, 2016 | Substantially Equivalent | ALCON LABORATORIES, INC. |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Nov 24, 2015 | Substantially Equivalent | ART OPTICAL CONTACT LENS, INC. |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Aug 10, 2015 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | Jul 10, 2015 | Substantially Equivalent | CONTAMAC LTD |
| K141348 | VISCO SOFT CONTACT LENS | Jun 22, 2015 | Substantially Equivalent | VISCO VISION INC. |
| K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Apr 30, 2015 | Substantially Equivalent | Visioneering Technologies, Inc. |
| K142820 | BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear | Apr 30, 2015 | Substantially Equivalent | ABB Optical Group, LLC |
| K143280 | BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens | Apr 23, 2015 | Substantially Equivalent | Brien Holden Vision Pty Ltd. |
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) | Apr 15, 2015 | Substantially Equivalent | I-SEE VISION TECHNOLOGY INC. |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | Mar 12, 2015 | Substantially Equivalent | INTEROJO INC. |
| K143431 | Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Feb 20, 2015 | Substantially Equivalent | i-codi Co., Ltd |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | Feb 13, 2015 | Substantially Equivalent | Bausch & Lomb Incorporated |
| K142641 | Intelliwave4 | Jan 12, 2015 | Substantially Equivalent | ART OPTICAL CONTACT LENS, INC. |
| K143052 | Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens | Dec 16, 2014 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Dec 12, 2014 | Substantially Equivalent | QUALIMED SRL |
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | Oct 30, 2014 | Substantially Equivalent | Unilens Corp., USA |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | Oct 17, 2014 | Substantially Equivalent | UNICON OPTICAL CO., LTD. |
| K140025 | AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | Oct 15, 2014 | Substantially Equivalent | Pegavision Corporation |
| K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | Oct 07, 2014 | Substantially Equivalent | NEO VISION CO., LTD. |
| K141699 | VASSEN COLOR | Oct 07, 2014 | Substantially Equivalent | VASSEN CO., LTD. |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | Sep 18, 2014 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K141280 | ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS | Jul 18, 2014 | Substantially Equivalent | SEINOH OPTICAL CO. LTD. |
| K133403 | FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS | Jun 11, 2014 | Substantially Equivalent | FIRESTONE OPTICS, INC. |
| K133735 | EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Mar 21, 2014 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT | Mar 05, 2014 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K132714 | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) | Mar 05, 2014 | Substantially Equivalent | VISION SCIENCE CO LTD |
| K133472 | SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) | Mar 04, 2014 | Substantially Equivalent | SOUFLON PHARMACEUTICALS LTD |
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | Jan 29, 2014 | Substantially Equivalent | CIBA VISION CORPORATION |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent | COOPERVISION, INC. |
| K132854 | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Dec 23, 2013 | Substantially Equivalent | YUNG SHENG OPTICAL CO., LTD. |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | Dec 20, 2013 | Substantially Equivalent | BAUSCH & LOMB INCORPORATED |
| K133079 | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | Dec 17, 2013 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | Sep 11, 2013 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K132146 | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) | Aug 30, 2013 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent | COOPERVISION, INC. |
| K130931 | EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent | JIANGSU HORIEN CONTACT LENS CO., LTD. |
| K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Aug 05, 2013 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K123431 | DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D | Jun 17, 2013 | Substantially Equivalent | DREAMCON CO., LTD |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | May 30, 2013 | Substantially Equivalent | COOPERVISION, INC. |
| K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE | May 13, 2013 | Substantially Equivalent | THE LAGADO CORP. |
| K123973 | AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | Apr 23, 2013 | Substantially Equivalent | Pegavision Corporation |
| K123484 | SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS | Mar 29, 2013 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K122220 | ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S | Mar 19, 2013 | Substantially Equivalent | SOFLEX LIMITED |
| K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | Feb 21, 2013 | Substantially Equivalent | CIBA VISION CORPORATION |
| K122315 | FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC | Feb 15, 2013 | Substantially Equivalent | OCULUS PRIVATE LIMITED |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | Dec 20, 2012 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K122213 | ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Dec 12, 2012 | Substantially Equivalent | SOFLEX LIMITED |
| K121201 | SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS | Oct 26, 2012 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K121652 | CVUE ADVANCED HYDRA VUE | Oct 05, 2012 | Substantially Equivalent | UNILENS CORP., USA |
| K121519 | ISIGHT | Sep 18, 2012 | Substantially Equivalent | C & E GP SPECIALISTS, INC. |
| K121324 | AVT NATURASOFT | Aug 23, 2012 | Substantially Equivalent | ADVANCED VISION TECHNOLOGIES |
| K112373 | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION | Aug 17, 2012 | Substantially Equivalent | INNOVA VISION INC. |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | Jun 05, 2012 | Substantially Equivalent | BAUSCH & LOMB INCORPORATED |
| K110835 | GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Apr 26, 2012 | Substantially Equivalent | GEO MEDICAL CO., LTD. |
| K120028 | AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES | Apr 17, 2012 | Substantially Equivalent | Pegavision Corporation |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | Apr 03, 2012 | Substantially Equivalent | COOPERVISION, INC. |
| K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | Mar 30, 2012 | Substantially Equivalent | CIBA VISION CORPORATION |
| K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | Dec 21, 2011 | Substantially Equivalent | COOPER VISION, INC. |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | Dec 02, 2011 | Substantially Equivalent | COOPERVISION, INC. |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | Dec 02, 2011 | Substantially Equivalent | COOPERVISION, INC. |
| K111267 | CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) | Nov 08, 2011 | Substantially Equivalent | ABBCONCISE OPTICAL GROUP, LLC |
| K111345 | SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS | Nov 02, 2011 | Substantially Equivalent | THE SEE CLEAR COMPANY, INC |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | Sep 15, 2011 | Substantially Equivalent | COOPERVISION, INC. |
| K103132 | FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI | Sep 08, 2011 | Substantially Equivalent | OCULUS PRIVATE LIMITED |
| K110261 | ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS | Jul 28, 2011 | Substantially Equivalent | SOFLEX LIMITED |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT | Jun 29, 2011 | Substantially Equivalent | COOPERVISION, INC. |
| K102895 | ONE DAY FLAT PACK | Apr 28, 2011 | Substantially Equivalent | MENICON CO. LTD. |
| K102557 | NOVAKONE SPHERICAL AND TORIC LENSES | Apr 26, 2011 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, | Apr 20, 2011 | Substantially Equivalent | UNILENS CORP., USA |
| K100456 | CVUE ADVANCED DEFINITIVE | Oct 28, 2010 | Substantially Equivalent | UNILENS CORP., USA |
| K100443 | DEFINITIVE, FLEXLENS - SILICONE HYDROGEL | Oct 28, 2010 | Substantially Equivalent | X-CEL CONTACTS, INC. |
| K100244 | METRO SOFT | Oct 28, 2010 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K100221 | INTELLIWAVE3 | Sep 14, 2010 | Substantially Equivalent | ART OPTICAL CONTACT LENS, INC. |
| K101122 | BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS | Aug 09, 2010 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K091327 | ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES | Jun 25, 2010 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | May 21, 2010 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K092852 | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Mar 11, 2010 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Jan 05, 2010 | Substantially Equivalent | COOPERVISION, INC. |
| K090806 | SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON | Dec 18, 2009 | Substantially Equivalent | SAFILENS, S.R.L. |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | Sep 03, 2009 | Substantially Equivalent | INNOVA VISION INC. |
| K082883 | EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR | Jun 16, 2009 | Substantially Equivalent | I-SEE VISION TECHNOLOGY INC |
| K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | Jun 16, 2009 | Substantially Equivalent | I-SEE VISION TECHNOLOGY INC |
| K082879 | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Jun 16, 2009 | Substantially Equivalent | I-SEE VISION TECHNOLOGY INC |
| K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Apr 14, 2009 | Substantially Equivalent | CIBA VISION CORPORATION |
| K080794 | POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Dec 17, 2008 | Substantially Equivalent | POLYVUE DISTRIBUTION, INC. |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | Sep 29, 2008 | Substantially Equivalent | COOPERVISION, INC. |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Sep 11, 2008 | Substantially Equivalent | UNILENS CORP., USA |
| K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Jul 23, 2008 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Jul 03, 2008 | Substantially Equivalent | ART OPTICAL CONTACT LENS, INC. |
| K080686 | WESTCON HORIZON 49% (HIOXIFILCON B) | Apr 22, 2008 | Substantially Equivalent | WESTCON CONTACT LENS CO. |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | Mar 03, 2008 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES | Feb 28, 2008 | Substantially Equivalent | CIBA VISION CORPORATION |
| K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Jan 24, 2008 | Substantially Equivalent | CIBA VISION CORPORATION |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Jan 04, 2008 | Substantially Equivalent | COOPERVISION, INC. |
| K062854 | BENZ-G 4X HIOXIFILCON D | Aug 06, 2007 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Jun 07, 2007 | Substantially Equivalent | INNOVA VISION INC. |
| K070308 | FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR | Mar 12, 2007 | Substantially Equivalent | X-CEL CONTACTS |
| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | Nov 14, 2006 | Substantially Equivalent | CIBA VISION CORPORATION |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | Nov 01, 2006 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K060821 | SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES | May 18, 2006 | Substantially Equivalent | SPECIALEYES LLC |
| K052290 | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS | May 15, 2006 | Substantially Equivalent | CLEARLAB PTE LTD. |
| K051477 | MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) | Mar 10, 2006 | Substantially Equivalent | MI GWANG CONTACT LENS CO., LTD. |
| K052606 | MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS | Dec 15, 2005 | Substantially Equivalent | MARIETTA VISION |
| K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | Dec 06, 2005 | Substantially Equivalent | COOPERVISION, INC. |
| K052703 | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL | Nov 10, 2005 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K051095 | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Aug 16, 2005 | Substantially Equivalent | OPTICAL CONNECTION, INC. |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Aug 12, 2005 | Substantially Equivalent | INNOVA VISION INC. |
| K051430 | EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) | Jul 18, 2005 | Substantially Equivalent | HYDROGEL VISION CORPORATION |
| K051184 | 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Jul 01, 2005 | Substantially Equivalent | UNITED CONTACT LENS, INC. |
| K050948 | PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS | May 18, 2005 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K050717 | PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC | May 13, 2005 | Substantially Equivalent | COOPERVISION, INC. |
| K050157 | MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS | Apr 26, 2005 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | Apr 13, 2005 | Substantially Equivalent | UNILENS CORP., USA |
| K040303 | 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS | Feb 02, 2005 | Substantially Equivalent | HYDROGEL VISION CORPORATION |
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | Feb 01, 2005 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K043129 | PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) | Jan 12, 2005 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K042824 | FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Nov 16, 2004 | Substantially Equivalent | COOPERVISION, INC. |
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | Oct 28, 2004 | Substantially Equivalent | VISTAKON |
| K042435 | COOPER PROSTHETIC | Oct 26, 2004 | Substantially Equivalent | COOPERVISION, INC. |
| K042242 | ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES | Sep 15, 2004 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K041700 | CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR | Jul 30, 2004 | Substantially Equivalent | CANTOR & NISSEL LTD. |
| K033655 | SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | Jul 30, 2004 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K041138 | LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS | Jul 23, 2004 | Substantially Equivalent | COOPERVISION, INC. |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | Jul 07, 2004 | Substantially Equivalent | UNILENS CORP., USA |
| K040900 | S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Jun 15, 2004 | Substantially Equivalent | OPTICAL CONNECTION, INC. |
| K033919 | CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS | Mar 12, 2004 | Substantially Equivalent | CIBA VISION CORPORATION |
| K033136 | I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 | Mar 05, 2004 | Substantially Equivalent | INNOVA VISION INC. |
| K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES | Feb 20, 2004 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Feb 04, 2004 | Substantially Equivalent | VISTAKON |
| K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | Nov 07, 2003 | Substantially Equivalent | COOPER VISION, INC. |
| K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | Oct 16, 2003 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K032256 | QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE | Aug 29, 2003 | Substantially Equivalent | NO 7 CONTACT LENS LABORATORY LTD. |
| K031532 | SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR | Aug 01, 2003 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K031477 | HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS | Jul 18, 2003 | Substantially Equivalent | OCULAR SCIENCES, INC. |
| K030842 | ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP | Jun 06, 2003 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K030593 | FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC | May 30, 2003 | Substantially Equivalent | X-CEL CONTACTS, A WALMAN CO. |
| K030748 | AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER | May 14, 2003 | Substantially Equivalent | CLEARLAB PTE LTD. |
| K030548 | SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Apr 04, 2003 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K030167 | MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER | Apr 02, 2003 | Substantially Equivalent | CLEARLAB PTE LTD. |
| K030027 | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% | Apr 01, 2003 | Substantially Equivalent | GELFLEX LABORATORIES |
| K023989 | CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Feb 26, 2003 | Substantially Equivalent | CONTAMAC LTD. |
| K023987 | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Feb 26, 2003 | Substantially Equivalent | CONTAMAC LTD. |
| K024045 | CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Feb 14, 2003 | Substantially Equivalent | CONTAMAC LTD. |
| K024003 | GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT | Feb 05, 2003 | Substantially Equivalent | GELFLEX |
| K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Jan 22, 2003 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K023791 | NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | Jan 10, 2003 | Substantially Equivalent | SOFTFOCAL COMPANY, INC. |
| K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Dec 24, 2002 | Substantially Equivalent | CONTAMAC LTD. |
| K023732 | CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Dec 10, 2002 | Substantially Equivalent | CIBA VISION CORPORATION |
| K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) | Dec 10, 2002 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | Nov 26, 2002 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K021907 | IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Sep 04, 2002 | Substantially Equivalent | IGEL VISION CARE PTE LTD. |
| K021720 | MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR | Aug 12, 2002 | Substantially Equivalent | SOFLEX ISRALENS CONTACT LENS LTD. |
| K021295 | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | Jun 04, 2002 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K020855 | IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT | Jun 04, 2002 | Substantially Equivalent | IGEL VISION CARE PTE LTD. |
| K020642 | SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | May 24, 2002 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | May 16, 2002 | Substantially Equivalent | BAUSCH & LOMB |
| K020608 | HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) | May 16, 2002 | Substantially Equivalent | POLY VUE TECHNOLGIES, INC. |
| K020917 | SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | May 06, 2002 | Substantially Equivalent | ST. SHINE OPTICAL CO., LTD. |
| K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS | Apr 26, 2002 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K020392 | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR | Apr 26, 2002 | Substantially Equivalent | COOPERVISION, INC. |
| K020139 | FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN | Apr 09, 2002 | Substantially Equivalent | CIBA VISION CORPORATION |
| K020193 | OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Feb 28, 2002 | Substantially Equivalent | CL MCINTOSH |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | Feb 26, 2002 | Substantially Equivalent | VISTAKON |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | Dec 26, 2001 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K013445 | OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES | Dec 26, 2001 | Substantially Equivalent | FLORIDA OPTICAL ENGINEERING, INC. |
| K013377 | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Dec 20, 2001 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K011893 | COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES | Dec 06, 2001 | Substantially Equivalent | CONTACT COLOR SRL |
| K013469 | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Nov 20, 2001 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K013467 | TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Nov 20, 2001 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K013220 | HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) | Nov 20, 2001 | Substantially Equivalent | POLY VUE TECHNOLGIES, INC. |
| K012425 | BIOMEDICS UV MULTIFOCAL | Oct 12, 2001 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K011072 | GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS | Aug 24, 2001 | Substantially Equivalent | GELFLEX |
| K011256 | TORIC LITE LENS | Jul 17, 2001 | Substantially Equivalent | SOFLEX CONTACT LENS INDUSTRIES LTD. |
| K002099 | S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- | Jul 09, 2001 | Substantially Equivalent | BESCON CO., LTD. |
| K001962 | S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- | Jul 09, 2001 | Substantially Equivalent | BESCON CO., LTD. |
| K011542 | SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) | Jun 26, 2001 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S | Jun 19, 2001 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K011316 | BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T | Jun 13, 2001 | Substantially Equivalent | AMERICAN CONTACT LENS, INC. |
| K011234 | BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L | Jun 13, 2001 | Substantially Equivalent | AMERICAN BIOCURVE, INC. |
| K011089 | SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C | May 23, 2001 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K004049 | POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) | May 23, 2001 | Substantially Equivalent | OPTECH, INC. |
| K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES | Apr 12, 2001 | Substantially Equivalent | VISTAKON |
| K010114 | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) | Apr 11, 2001 | Substantially Equivalent | JOHNSON & JOHNSON VISION CARE, INC. |
| K010256 | ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL | Mar 26, 2001 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K010223 | BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) | Mar 16, 2001 | Substantially Equivalent | AMERICAN CONTACT LENS, INC. |
| K010218 | VISTAKON (HEFILCON C) CONTACT LENSES | Mar 16, 2001 | Substantially Equivalent | VISTAKON |
| K010126 | PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Mar 12, 2001 | Substantially Equivalent | CL-TINTERS |
| K003861 | BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) | Mar 08, 2001 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT | Feb 21, 2001 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR | Feb 21, 2001 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K003789 | SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT | Feb 21, 2001 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K003833 | SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Feb 13, 2001 | Substantially Equivalent | CLEARLAB PTE LTD. |
| K001585 | BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE | Feb 13, 2001 | Substantially Equivalent | AMERICAN BIOCURVE, INC. |
| K003526 | SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) | Feb 12, 2001 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K003042 | V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT | Jan 22, 2001 | Substantially Equivalent | JOE B. GOLDBERG, O.D. |
| K003136 | OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Jan 06, 2001 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K003170 | RYTHMIC AND RYTHMIC UV | Dec 15, 2000 | Substantially Equivalent | ESSILOR INTL. |
| K003161 | ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT | Dec 15, 2000 | Substantially Equivalent | LES LABORATOIRES BLANCHARD |
| K003071 | GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Dec 13, 2000 | Substantially Equivalent | CIBA VISION CORPORATION |
| K003079 | SPECIALTY TINT SOFT CONTACT LENS | Nov 21, 2000 | Substantially Equivalent | SPECIALTY TINT |
| K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | Nov 08, 2000 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | Oct 17, 2000 | Substantially Equivalent | UNILENS CORP., USA |
| K002647 | MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS | Sep 13, 2000 | Substantially Equivalent | MARIETTA CONTACT LENS SERVICE |
| K002625 | METHAFILCON A | Sep 13, 2000 | Substantially Equivalent | COOPERVISION, INC. |
| K001908 | KONTUR 55 SOFT LENS | Aug 18, 2000 | Substantially Equivalent | KONTUR KONTACT LENS CO., INC. |
| K001227 | ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT | Jun 29, 2000 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K001620 | METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN | Jun 13, 2000 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K001584 | METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT | Jun 13, 2000 | Substantially Equivalent | MED VICE CONSULTING, INC. |
| K001090 | METHAFILCON A | May 19, 2000 | Substantially Equivalent | COOPERVISION, INC. |
| K001089 | POLYMACON | May 19, 2000 | Substantially Equivalent | COOPERVISION, INC. |
| K993489 | CRYSTAL CUSTOM TINTED SOFT CONTACT LENS | Apr 14, 2000 | Substantially Equivalent | CRYSTAL REFLECTIONS, INT., INC. |
| K000529 | LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) | Mar 21, 2000 | Substantially Equivalent | THE LIFESTYLE CO., INC. |
| K000376 | SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT | Mar 21, 2000 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K994335 | PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS | Mar 20, 2000 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K000439 | DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C | Mar 20, 2000 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K000384 | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX | Mar 06, 2000 | Substantially Equivalent | COOPERVISION, INC. |
| K994125 | BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES | Mar 03, 2000 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K994324 | ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Feb 23, 2000 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K994318 | VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Feb 23, 2000 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K993580 | SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | Feb 02, 2000 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K993935 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI | Dec 21, 1999 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K983637 | ACTIFRESH 400 LENS | Dec 10, 1999 | Substantially Equivalent | HYDRON LTD. |
| K992264 | OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Nov 24, 1999 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K992950 | CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS | Nov 18, 1999 | Substantially Equivalent | PROSTHETIC SOFT LENS CORP. |
| K991015 | LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) | Nov 02, 1999 | Substantially Equivalent | LAMDA POLYTECH LTD. |
| K992692 | EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS | Oct 18, 1999 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K992466 | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR | Oct 04, 1999 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K992589 | RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY | Aug 26, 1999 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K992500 | CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | Aug 18, 1999 | Substantially Equivalent | CANTOR & SILVER LTD. |
| K992339 | COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS | Aug 16, 1999 | Substantially Equivalent | COLORSOFT LABORATORIES CORP. |
| K992054 | ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS | Jul 07, 1999 | Substantially Equivalent | ADVENTURES IN COLOR TECHNOLOGY, LTD. |
| K984090 | SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) | Jul 07, 1999 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K992010 | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) | Jun 29, 1999 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K991000 | GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES | Jun 28, 1999 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K991163 | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | Jun 08, 1999 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K990815 | COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS | Jun 03, 1999 | Substantially Equivalent | COLORSOFT LABORATORIES CORP. |
| K991550 | FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS | May 14, 1999 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K990011 | CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | May 11, 1999 | Substantially Equivalent | CONTINENTAL SOFT LENS, INC. |
| K984098 | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS | May 10, 1999 | Substantially Equivalent | ADVENTURES IN COLOR TECHNOLOGY, LTD. |
| K991134 | ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | May 06, 1999 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K990757 | CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA | Apr 21, 1999 | Substantially Equivalent | CANTOR & SILVER LTD. |
| K990281 | S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Apr 16, 1999 | Substantially Equivalent | NISSEL LTD. |
| K983496 | RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T | Mar 29, 1999 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K990606 | TETRAFILCON A | Mar 15, 1999 | Substantially Equivalent | COOPERVISION, INC. |
| K983160 | ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR | Feb 18, 1999 | Substantially Equivalent | HYDRON LTD. |
| K984523 | IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS | Feb 16, 1999 | Substantially Equivalent | IGEL VISION CARE PTE LTD. |
| K982947 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS | Jan 29, 1999 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K983912 | VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER | Jan 26, 1999 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K984259 | PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Jan 21, 1999 | Substantially Equivalent | CL-TINTERS |
| K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | Jan 21, 1999 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K982997 | FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) | Jan 20, 1999 | Substantially Equivalent | ASPECT VISION CARE, LTD. |
| K982988 | PRECISION UV (VASURFILCON A) | Jan 06, 1999 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K983773 | BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | Dec 22, 1998 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K982344 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS | Dec 22, 1998 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K983278 | OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) | Nov 25, 1998 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K983894 | BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS | Nov 18, 1998 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K983021 | METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC | Nov 13, 1998 | Substantially Equivalent | METROSOFT, INC. |
| K982110 | POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Nov 06, 1998 | Substantially Equivalent | OPTECH, INC. |
| K983053 | ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) | Oct 21, 1998 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K982774 | SOFT (HYDROPHILIC) CONTACT LENSES | Sep 02, 1998 | Substantially Equivalent | CL-TINTERS |
| K982904 | ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS | Sep 01, 1998 | Substantially Equivalent | LES LABORATOIRES BLANCHARD |
| K974837 | IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS | Jul 06, 1998 | Substantially Equivalent | IGEL VISION CARE PTE LTD. |
| K981779 | CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT | Jun 24, 1998 | Substantially Equivalent | CANTOR & SILVER LTD. |
| K981252 | OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) | Jun 23, 1998 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K980649 | PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS | May 13, 1998 | Substantially Equivalent | COOPERVISION, INC. |
| K980634 | FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Apr 22, 1998 | Substantially Equivalent | ASPECT VISION CARE, LTD. |
| K974408 | PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS | Apr 16, 1998 | Substantially Equivalent | BIOCOMPATIBLES EYEWEAR, INC. |
| K980554 | ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) | Apr 07, 1998 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K980818 | POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) | Mar 30, 1998 | Substantially Equivalent | STEPHEN A. DUNN, INC. |
| K980218 | METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Mar 23, 1998 | Substantially Equivalent | BIOCOMPATIBLES EYEWEAR, INC. |
| K974780 | SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS | Mar 11, 1998 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K974599 | ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) | Mar 02, 1998 | Substantially Equivalent | OPTI-CENTRE LABORATORIES |
| K980418 | BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER | Feb 27, 1998 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K963013 | PREFERENCE 60 AND PREFERENCE 60 TORIC | Dec 19, 1997 | Substantially Equivalent | COOPERVISION, INC. |
| K973967 | AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) | Dec 08, 1997 | Substantially Equivalent | ALDEN OPTICAL LABS., INC. |
| K973847 | AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS | Dec 08, 1997 | Substantially Equivalent | MARTIN DALSING |
| K973597 | AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS | Nov 20, 1997 | Substantially Equivalent | MARTIN DALSING |
| K973192 | FLEXLENS, FLEXLENS TORIC | Nov 20, 1997 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K972807 | (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI | Oct 15, 1997 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR | Aug 26, 1997 | Substantially Equivalent | ASPECT VISION CARE, LTD. |
| K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | Aug 20, 1997 | Substantially Equivalent | OCULAR SCIENCES PUERTO RICO, INC. |
| K972454 | OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS | Aug 08, 1997 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K971647 | LL BI-FOCAL, DAILY WEAR CONTACT LENS | Jul 15, 1997 | Substantially Equivalent | LOMBART LENSES, LTD. |
| K971164 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | May 21, 1997 | Substantially Equivalent | ASPECT VISION CARE, LTD. |
| K971049 | FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | May 21, 1997 | Substantially Equivalent | ASPECT VISION CARE, LTD. |
| K971515 | PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) | May 20, 1997 | Substantially Equivalent | BIOMED DEVICES CORP. |
| K965052 | D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES | May 14, 1997 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K970746 | SEE3 (LOTRAFILCON A) SOFT CONTACT LENS | May 09, 1997 | Substantially Equivalent | CIBA VISION CORPORATION |
| K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | Apr 03, 1997 | Substantially Equivalent | BIOCOMPATIBLES EYEWEAR, INC. |
| K970312 | CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) | Apr 02, 1997 | Substantially Equivalent | FLEXLENS, INC. |
| K970019 | MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS | Mar 25, 1997 | Substantially Equivalent | MENICON U.S.A., INC. |
| K970615 | PROMED 55-G SOFT DAILY WEAR CONTACT LENS | Mar 19, 1997 | Substantially Equivalent | BIOMED DEVICES CORP. |
| K965012 | LIFESTYLE BREAK THRU (POLYMACON) | Mar 11, 1997 | Substantially Equivalent | THE LIFESTYLE CO., INC. |
| K964902 | CONTACT LENSES METRO-G 3X (HIOXIFILCON B) | Mar 11, 1997 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K963001 | LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Mar 11, 1997 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K964528 | (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT | Mar 07, 1997 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K964696 | SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS | Feb 20, 1997 | Substantially Equivalent | SUNSOFT CORP. |
| K964612 | VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT | Jan 30, 1997 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K963764 | SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR | Jan 30, 1997 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K963837 | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN | Dec 20, 1996 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K962185 | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS | Dec 17, 1996 | Substantially Equivalent | COOPERVISION, INC. |
| K963011 | LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Nov 29, 1996 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K962911 | CONTACT LENS WITH COLOR ADDITIVE | Nov 29, 1996 | Substantially Equivalent | CAL BIONICS |
| K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS | Nov 27, 1996 | Substantially Equivalent | CIBA VISION CORPORATION |
| K963488 | SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED) | Nov 20, 1996 | Substantially Equivalent | SPECIALTY ULTRAVISION, INC. |
| K961606 | METRO FOCAL ASPHERIC (POLYMACON) | Nov 20, 1996 | Substantially Equivalent | METRO OPTICS OF AUSTIN, INC. |
| K962957 | RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT | Oct 01, 1996 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K962804 | ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER | Oct 01, 1996 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K962000 | FLEXLENS(METHAFILCON A) | Oct 01, 1996 | Substantially Equivalent | FLEXLENS, INC. |
| K961943 | FLEXLENS | Oct 01, 1996 | Substantially Equivalent | FLEXLENS, INC. |
| K961299 | PRECISION UV (VASURFILCON A) | Oct 01, 1996 | Substantially Equivalent | PILKINGTON BARNES-HIND, LTD. |
| K962711 | GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS | Sep 05, 1996 | Substantially Equivalent | GELFLEX LABORATORIES |
| K962710 | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Sep 05, 1996 | Substantially Equivalent | GELFLEX LABORATORIES |
| K962121 | HORIZON/WESTHIN 55-G | Aug 26, 1996 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K961103 | BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT | Aug 23, 1996 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K961428 | SOFT-55 DAILY WEAR CONTACT LENS | May 21, 1996 | Substantially Equivalent | LOMBART LENSES, LTD. |
| K950294 | FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS | Apr 11, 1996 | Substantially Equivalent | FLEXLENS, INC. |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Apr 10, 1996 | Substantially Equivalent | UNILENS CORP., USA |
| K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent | UNILENS CORP., USA |
| K960376 | FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent | UNILENS CORP., USA |
| K954524 | W-55 (METHAFILON A) CONTACT LENS | Mar 28, 1996 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K960291 | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS | Mar 25, 1996 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K953807 | DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS | Feb 14, 1996 | Substantially Equivalent | STEPHEN A. DUNN, INC. |
| K954603 | DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT | Jan 04, 1996 | Substantially Equivalent | WESLEY JESSEN CORP. |
| K953199 | METRO 55G TORIC & SPHERICAL | Dec 11, 1995 | Substantially Equivalent | METROSOFT, INC. |
| K952620 | OPTICAL BLANKS: BENZ55G CLEAR AND VISIBILITY TINTED | Dec 01, 1995 | Substantially Equivalent | BENZ RESEARCH AND DEVELOPMENT CORP. |
| K954139 | AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS | Nov 24, 1995 | Substantially Equivalent | COOPERVISION, INC. |
| K951893 | LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS | Nov 17, 1995 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K953804 | VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS | Sep 26, 1995 | Substantially Equivalent | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
| K952152 | PROCLEAR DAILY WEAR CONTACT LENS | Jul 27, 1995 | Substantially Equivalent | BIOCOMPATIBLES LTD. |
| K950968 | TETRAFILCON A HYDROPHILIC CONTACT LENSES | Jul 25, 1995 | Substantially Equivalent | COOPERVISION, INC. |
| K952261 | HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% | Jul 05, 1995 | Substantially Equivalent | PILKINGTON BARNES-HIND, LTD. |
| K942374 | ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS | Apr 13, 1995 | Substantially Equivalent | SUNSOFT CORP. |
| K951180 | ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Apr 07, 1995 | Substantially Equivalent | SZABOCSIK AND ASSOC. |
| K943178 | DELTA | Apr 07, 1995 | Substantially Equivalent | VENTURE MANAGEMENT CORP. |
| K940848 | GELFLEX | Apr 07, 1995 | Substantially Equivalent | VENTURE MANAGEMENT CORP. |
| K950818 | HORIZON 55 BI-CON TORIC | Mar 21, 1995 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K950283 | LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS | Feb 07, 1995 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K945981 | LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS | Feb 07, 1995 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K946012 | PRECISION UV(TM) (VASURFICON A) | Jan 24, 1995 | Substantially Equivalent | PILKINGTON BARNES-HIND, LTD. |
| K945365 | HORIZON 55 BI-CON | Dec 28, 1994 | Substantially Equivalent | WESTCON CONTACT LENS CO., INC. |
| K944895 | BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS | Dec 19, 1994 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K941998 | OCU-FLEX-38 (POLYMACON) | Oct 13, 1994 | Substantially Equivalent | OCU-EASE OPTICAL PRODUCTS, INC. |
| K944722 | PRECISION UV(TM) (VASURFILCON A) | Oct 03, 1994 | Substantially Equivalent | PILKINGTON BARNES-HIND, LTD. |
| K942494 | LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS | Sep 08, 1994 | Substantially Equivalent | PERMEABLE TECHNOLOGIES, INC. |
| K943490 | CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES | Aug 11, 1994 | Substantially Equivalent | CONTINENTAL SOFT LENS, INC. |
| K942302 | ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS | Aug 05, 1994 | Substantially Equivalent | PREFERRED OPTICS, INC. |
| K942214 | H55 HYDROPHILIC CONTACT LENS | Jul 28, 1994 | Substantially Equivalent | MARTIN S. KNOPF ASSOC., INC. |
| K942187 | ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Jul 28, 1994 | Substantially Equivalent | SZABOCSIK AND ASSOC. |
| K942186 | ESSTECH PS ASPHERIC | Jul 28, 1994 | Substantially Equivalent | SZABOCSIK AND ASSOC. |
| K942372 | SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS | Jul 07, 1994 | Substantially Equivalent | UNILENS CORP., USA |
| K941836 | UNILENS 38 SOFT ASPHERIC CONTACT LENS | Jul 07, 1994 | Substantially Equivalent | UNILENS CORP., USA |
| K941877 | LL-55 (METHAFILCON A) FOR DAILY WEAR | Jun 14, 1994 | Substantially Equivalent | LOMBART LENSES, LTD. |
| K941484 | DAILY WEAR SOFT CONTACT LENSES | Jun 09, 1994 | Substantially Equivalent | CIBA VISION CORPORATION |
| K941607 | UCL MULTIFOCAL SOFT CONTACT LENS | Jun 06, 1994 | Substantially Equivalent | UNITED CONTACT LENS, INC. |
| K941370 | BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS | May 27, 1994 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K940777 | BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | Apr 12, 1994 | Substantially Equivalent | UNILENS CORP., USA |
FEI Numbers
This FDA classification entry is associated with 135 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 135 registration numbers. Click on an entry to view related FDA registrations.