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510(k) Data Aggregation

    K Number
    K050623
    Device Name
    VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
    Manufacturer
    VOLK OPTICAL, INC.
    Date Cleared
    2005-03-28

    (18 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    VOLK OPTICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
    Device Description
    The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.
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    K Number
    K023221
    Device Name
    CONTACT LASER & DIAGNOSTIC LENSES
    Manufacturer
    VOLK OPTICAL, INC.
    Date Cleared
    2002-10-11

    (14 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    VOLK OPTICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.
    Device Description
    Not Found
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