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

    NEUROLUMEN PN-1000

    K Number: K142025 · Decision Jan 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    180

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    Basic Information

    Device Name
    NEUROLUMEN PN-1000
    K Number
    K142025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurolumen, LLC
    Date Received
    July 25, 2014
    Decision Date
    January 21, 2015
    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 Neurolumen, LLC

    K Number Device Name
    K082223 NEUTROLUMENPN SYSTEM, MODEL 1000