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510(k) Data Aggregation

    K Number
    K171157
    Device Name
    PolyDev Soft Contact Lenses
    Manufacturer
    Date Cleared
    2017-06-02

    (43 days)

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

    Polydev Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Toricolors (hioxifilcon D) Soft Contact Lenses for daily wear (power range -12.00D to +6.00D) is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. Eye care practitioners may prescribe the lens 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 disinfection system. The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
    Device Description
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    K Number
    K161931
    Device Name
    Toricolors (hioxifilcon D) Soft Contact Lenses
    Manufacturer
    Date Cleared
    2016-10-12

    (90 days)

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

    POLYDEV LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 1.25 Diopters. Eye care practitioners may prescribe the lens 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 disinfection system. The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
    Device Description
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    K Number
    K160977
    Device Name
    PolyDev Soft Contact Lenses
    Manufacturer
    Date Cleared
    2016-07-13

    (97 days)

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

    Polydev Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. Eye care practitioners may prescribe the lens 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 disinfection system. The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
    Device Description
    Not Found
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