BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇩🇪 Germany

    OSRAM ULTRAMED 400 W

    K Number: K863937 · Decision Nov 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    OSRAM ULTRAMED 400 W
    K Number
    K863937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Osram GmbH
    Date Received
    October 9, 1986
    Decision Date
    November 4, 1986
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Osram GmbH

    K Number Device Name
    K812853 OSRAM UVA LAMP