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510(k) Data Aggregation

    K Number
    K110835
    Device Name
    GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    GEO MEDICAL CO., LTD.
    Date Cleared
    2012-04-26

    (398 days)

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

    GEO MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakit and/or not rol ually weat to contection of Formative astigmative astigmatism up to 0.50 dioplers aphakic persons with non discussu eyos the ons is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule).
    Device Description
    GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens
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