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510(k) Data Aggregation

    K Number
    K082391
    Device Name
    PRIMAEVA MEDICAL RENESIS SYSTEM
    Manufacturer
    PRIMAEVA MEDICAL, INC.
    Date Cleared
    2009-09-01

    (378 days)

    Product Code
    GEI, PRE
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMAEVA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primaeva Medical Miratone System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
    Device Description
    The Primaeva Medical Miratone System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface; a reusable cooler controller; cooler handpiece/applicator; a reusable reusable a electrode insertion device/applicator; and a single patient use, disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.
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    K Number
    K080145
    Device Name
    PRIMAEVA MEDICAL SYSTEM
    Manufacturer
    PRIMAEVA MEDICAL, INC.
    Date Cleared
    2008-02-28

    (37 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMAEVA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primaeva Medical Finesse System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The Primaeva Medical System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface, a reusable cooler controller, a reusable cooling system handpiece, a reusable electrode insertion device and a disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.
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    K Number
    K072261
    Device Name
    FINESSE SYSTEM
    Manufacturer
    PRIMAEVA MEDICAL, INC.
    Date Cleared
    2007-12-26

    (134 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMAEVA MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized. The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator. The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle. The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.
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