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510(k) Data Aggregation

    K Number
    K021720
    Device Name
    MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
    Date Cleared
    2002-08-12

    (80 days)

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

    SOFLEX ISRALENS CONTACT LENS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 0.75 diopters. The lens may be disinfected using a chemical disinfection system.
    Device Description
    MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear
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