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

    CONTACT LASER & DIAGNOSTIC LENSES

    K Number: K023221 · Decision Oct 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    14

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    Basic Information

    Device Name
    CONTACT LASER & DIAGNOSTIC LENSES
    K Number
    K023221
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Volk Optical, Inc.
    Date Received
    September 27, 2002
    Decision Date
    October 11, 2002
    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
    K151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
    K050623 VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
    K943125 QUADRASPHERIC FUNDUS LENS