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

    Palm NRG cellulite body device (model: Palm NRG body device)

    K Number: K214015 · Decision Sep 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    278

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    Basic Information

    Device Name
    Palm NRG cellulite body device (model: Palm NRG body device)
    K Number
    K214015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heat IN A Click, LLC
    Date Received
    December 22, 2021
    Decision Date
    September 26, 2022
    Product Code
    PBX
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

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