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

    VISUMAX LASER KERATOME

    K Number: K100253 · Decision Jul 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    62
    Same Product Code
    176
    Applicant Total
    21
    Review Days
    161

    Basic Information

    Device Name
    VISUMAX LASER KERATOME
    K Number
    K100253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CARL ZEISS MEDITEC AG
    Date Received
    January 28, 2010
    Decision Date
    July 8, 2010
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HQF Laser, Ophthalmic

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