BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    Newa Skin Therapy System

    K Number: DEN150005 · Decision Dec 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    336

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    Basic Information

    Device Name
    Newa Skin Therapy System
    K Number
    DEN150005
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4420
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Endymed Medical, Ltd.
    Date Received
    January 16, 2015
    Decision Date
    December 18, 2015
    Product Code
    PAY
    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
    PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

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