BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

    K Number: K151961 · Decision Aug 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    33

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    Basic Information

    Device Name
    Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
    K Number
    K151961
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volk Optical, Inc.
    Date Received
    July 16, 2015
    Decision Date
    August 18, 2015
    Product Code
    HJK
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

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    Other Clearances by Volk Optical, Inc.

    K Number Device Name
    K050623 VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
    K023221 CONTACT LASER & DIAGNOSTIC LENSES
    K943125 QUADRASPHERIC FUNDUS LENS