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

    ULTRA-LUX LIGHT SOURCE

    K Number: K870898 · Decision Mar 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    238
    Review Days
    13

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    Basic Information

    Device Name
    ULTRA-LUX LIGHT SOURCE
    K Number
    K870898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medline Industries, Inc.
    Date Received
    March 5, 1987
    Decision Date
    March 18, 1987
    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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