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

    DERMALIGHT PSORACOMB

    K Number: K903660 · Decision Jul 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    341

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    Basic Information

    Device Name
    DERMALIGHT PSORACOMB
    K Number
    K903660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Solitec GmbH
    Date Received
    August 10, 1990
    Decision Date
    July 17, 1991
    Product Code
    IOB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IOB Lamp, Infrared, Non Heating

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