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

    XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)

    K Number: K013511 · Decision Feb 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    102

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    Basic Information

    Device Name
    XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
    K Number
    K013511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aculux, Inc.
    Date Received
    October 22, 2001
    Decision Date
    February 1, 2002
    Product Code
    FSW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FSW Light, Surgical, Endoscopic

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