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

    INFRALUX HEAT LAMP

    K Number: K864714 · Decision Mar 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    INFRALUX HEAT LAMP
    K Number
    K864714
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Infralux International, Inc.
    Date Received
    December 3, 1986
    Decision Date
    March 12, 1987
    Product Code
    ILY
    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
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Infralux International, Inc.

    K Number Device Name
    K900384 INFRAVIB MASSAGER - MODEL PR-1000