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

    MED RF 4000

    K Number: K210077 · Decision Dec 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    339

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    Basic Information

    Device Name
    MED RF 4000
    K Number
    K210077
    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
    F Care Systems USA, LLC
    Date Received
    January 12, 2021
    Decision Date
    December 17, 2021
    Product Code
    ONQ
    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
    ONQ Electrosurgical Coagulation For Aesthetic

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    Other Clearances by F Care Systems USA, LLC

    K Number Device Name
    K253918 Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
    K252704 F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
    K220725 HPR45i