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

    LITECURE THERAPY COMPACT

    K Number: K121487 · Decision Jun 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    7
    Review Days
    25

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    Basic Information

    Device Name
    LITECURE THERAPY COMPACT
    K Number
    K121487
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Litecure, LLC
    Date Received
    May 18, 2012
    Decision Date
    June 12, 2012
    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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