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

    SERENITY PRO PSF SYSTEM

    K Number: K071943 · Decision Aug 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    SERENITY PRO PSF SYSTEM
    K Number
    K071943
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inolase 2002, Ltd.
    Date Received
    July 13, 2007
    Decision Date
    August 10, 2007
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Inolase 2002, Ltd.

    K Number Device Name
    K062589 SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM