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510(k) Data Aggregation

    K Number
    K243868
    Device Name
    Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2025-07-02

    (197 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242056
    Device Name
    miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
    Manufacturer
    BenQ Materials Corporation
    Date Cleared
    2025-04-17

    (276 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    **miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus** is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. **miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus** is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The color lens may enhance or alter the apparent color of the eye. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. **miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus** are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required. **miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus** are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The lenses may enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
    Device Description
    **miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus** - They are daily wear soft contact lens for frequent replacement - They are in a spherical lens design with UV blocker. - They are available in hemispherical shell. - The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. - The water content is 46%. - A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm. - The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose. - The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye. - The lens is supplied in a sterile state, packaged in a buffered saline solution. **miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus** - They are daily wear soft contact lens for daily disposable - They are in a spherical lens desing with UV blocker. - They are available in hemispherical shell. - The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. - The water content is 48%. - A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm. - The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose. - The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye. - The lens is supplied in a sterile state, packaged in a buffered saline solution.
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    K Number
    K243953
    Device Name
    Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
    Manufacturer
    VizionFocus Inc.
    Date Cleared
    2025-04-10

    (108 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients. Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
    Device Description
    The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN). The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green. When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green contact lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm. The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm). The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.
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    K Number
    K241884
    Device Name
    HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
    Manufacturer
    Hunan Haipuming Technology Co., Ltd.
    Date Cleared
    2025-03-20

    (265 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use. Frequent / Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
    Device Description
    HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution. HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Titanium dioxide, Iron oxides, Solvent Yellow 18, Carbazole violet, Pigment Blue 36, Phthalocyanine green. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Back vertex power -10.00D to 0.00D, step: 0.25D; Base curve 8.40 mm to 8.70 mm, step: 0.10 mm; Total diameter 13.80 mm to 14.50 mm, step:0.10 mm. The physical properties of the proposed lens are: Specific gravity 1.124; Refractive index 1.437; Light Transmission 93% ± 5%; Surface character Hydrophilic; Water content 38%; Oxygen permeability 8.99x10^-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C. HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.
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    K Number
    K242916
    Device Name
    Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
    Manufacturer
    Largan Medical Co., Ltd.
    Date Cleared
    2025-02-04

    (133 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequentl planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal. therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.
    Device Description
    The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia. The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by crosslinking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. The lenses contain a combination of the following color additives: Phthalocyanine green, Carbazole violet, [Phthalocyaninato (2-)] copper, Titanium dioxide, Iron oxides (Red, Yellow and Black),and Mica-based pearlscent pigment (Gold, Silver and Red). All color additives used are listed in 21 CFR 73 subpart D and 74 subpart D. It is supplied in a sterile package with buffered saline solution.
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    K Number
    K243909
    Device Name
    Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
    Manufacturer
    Alcon Laboratories, Inc.
    Date Cleared
    2025-01-13

    (25 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism. Precision1 lenses are to be prescribed for single use, daily disposable wear, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. Dailies Total1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Dailies Total1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia. with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. Dailies Total1 for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. Dailies Total 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only. Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packs are packaged into carton boxes available in different pack sizes. Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design. Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.
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    K Number
    K242413
    Device Name
    VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
    Manufacturer
    VizionFocus Inc.
    Date Cleared
    2024-12-17

    (125 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere/Asphere: The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Toric: The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters. Multifocal: The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. The VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye.
    Device Description
    The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from mififilcon A. which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lenses consist of 40.0% mififilcon A and 60.0% water by weight when immersed in saline solution. The mififilcon A name has been adopted by the United States Adopted Names Council (USAN). The VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus Color (miffilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green, Mica. When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm. The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >80% in the UVA range (316mm - 380mm). The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are manufactured in spherical/aspheric, toric, and multifocal design configurations.
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    K Number
    K232839
    Device Name
    Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
    Manufacturer
    Yung Sheng Optical Co., Ltd.
    Date Cleared
    2024-12-16

    (459 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance. DISPOSABLE WEAR When prescribed for Disposable Wear, the lens is to be discarded after each removal.
    Device Description
    The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.
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    K Number
    K240918
    Device Name
    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
    Manufacturer
    Bruno Vision Care, LLC
    Date Cleared
    2024-10-25

    (205 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 1.00D or less of astigmatism. Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 4.00D or less of astigmatism The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
    Device Description
    The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking are manufactured in spherical or toric configurations. The lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2v1)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocvanine) to make the lens more visible for handling.
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    K Number
    K242391
    Device Name
    Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
    Manufacturer
    LUCENS TECHNOLOGY Co., Ltd.
    Date Cleared
    2024-10-08

    (57 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Product Code :

    LPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity. The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters. The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal design is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity. The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal-toric design is indicated for daily wear for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters. Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement, or for single-use disposable wear. When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
    Device Description
    The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is for daily wear and is fully molded in the sphere, toric, multifocal-toric design configurations. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from senofilcon C, which contains silicone hydrogel material and other hydrophilic monomers. The lens consists of 59.0% senofilcon C and 41.0% water by weight when immersed in saline solution. The senofilcon C name has been adopted by the United States Adopted Names Council (USAN). The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens contains Reactive Blue 246 (21 CFR Part 73.3106) for visibility and handling. The Lucens 41 (senofileon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315nm - 380mm).
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