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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Largan Medical Co., Ltd

    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
    K233501
    Device Name
    “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
    Manufacturer
    Largan Medical Co., Ltd
    Date Cleared
    2024-07-26

    (269 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largan Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K202129
    Device Name
    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
    Manufacturer
    Largan Medical Co., Ltd.
    Date Cleared
    2021-04-01

    (244 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largan Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic 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. The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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 frequent/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 disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.
    Device Description
    The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.
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    K Number
    K182674
    Device Name
    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
    Manufacturer
    Largan Medical Co., Ltd
    Date Cleared
    2018-11-13

    (48 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largan Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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 frequent/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(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatisam and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 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. It is supplied in a sterile package with buffered saline solution.
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    K Number
    K182523
    Device Name
    Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
    Manufacturer
    Largan Medical Co., Ltd.
    Date Cleared
    2018-11-01

    (49 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largan Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia) and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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 frequent/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 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, hyperopia. astigmatisam and presbyopia. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA), Methacrylic acid (MAA) and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of saline immersed in normal saline. 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, Mica-based pearlscent pigment, and Chromium-cobalt-aluminum oxide. All color additives used are listed in 21 CFR 73 Subpart D and 74 Subpart D.
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