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

    Contour Light CL-100

    K Number: K202955 · Decision May 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    231

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    Basic Information

    Device Name
    Contour Light CL-100
    K Number
    K202955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contour Research, LLC
    Date Received
    September 30, 2020
    Decision Date
    May 19, 2021
    Product Code
    OLI
    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
    OLI Fat Reducing Low Level Laser

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    Other Clearances by Contour Research, LLC

    K Number Device Name
    K243854 Contour Light (CL-100)