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510(k) Data Aggregation

    K Number
    K082197
    Device Name
    RHYTEC, INC., PORTRAIT PSR
    Manufacturer
    RHYTEC INCORPORATED
    Date Cleared
    2008-08-22

    (18 days)

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

    RHYTEC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portrait® PSR3 System is intended for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides - Superficial skin lesions - Actinic Keratosis - Viral Papillomata - Seborrhoeic Keratosis - Acne Scars
    Device Description
    The Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based and RF-based dermatological surgical and skin resurfacing technologies. The system includes: - Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket. - Footswitch - single pedal unit for activation - Handpiece and Cable Assembly carries RF power and Nitrogen gas to the Nozzle. - Treatment Pack comprising a disposable Nozzle that is connected to the Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment. - Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.
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    K Number
    K073111
    Device Name
    PORTRAIT PSR, MODEL 745915
    Manufacturer
    RHYTEC INCORPORATED
    Date Cleared
    2008-03-27

    (143 days)

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

    RHYTEC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portrait® PSR3 System is intended for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides - Superficial skin lesions - Actinic Keratosis - Viral Papillomata - Seborrhoeic Keratosis - Acne Scars
    Device Description
    The Portrait® PSR is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based dermatological surgical and skin resurfacing technologies. The system includes: - Portrait® PSR3 Generator - Footswitch - Handpiece and Cable Assembly - Treatment Pack comprising a disposable Nozzle and an electronic "treatment pack key" - Nitrogen Gas Cylinder
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    K Number
    K072394
    Device Name
    PORTRAIT STAND-OFF
    Manufacturer
    RHYTEC INCORPORATED
    Date Cleared
    2007-09-12

    (16 days)

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

    RHYTEC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portrait® PSR3 System is intended for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides . - Superficial skin lesions . - Actinic Keratosis . - Viral Papillomata . - Seborrhoeic Keratosis . The indications are unchanged from K071886.
    Device Description
    The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen gas into plasma within the Handpiece. The plasma emerges from the Nozzle at the distal end of the Handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the Handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predicy able tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin. The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.
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    K Number
    K071786
    Device Name
    PORTRAIT PSR
    Manufacturer
    RHYTEC INCORPORATED
    Date Cleared
    2007-07-26

    (24 days)

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

    RHYTEC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portrait® PSR³ is indicated for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides - Superficial skin lesions - Actinic Keratosis - Viral Papillomata - Seborrhoeic Keratosis
    Device Description
    The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
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    K Number
    K060948
    Device Name
    PORTRAIT PSR3
    Manufacturer
    RHYTEC INCORPORATED
    Date Cleared
    2006-09-05

    (152 days)

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

    RHYTEC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portrait PSR3 is indicated for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides . - . Superficial skin lesions - . Actinic Keratosis - . Viral Papillomata - . Seborrhoeic Keratosis
    Device Description
    The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
    Ask a Question

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