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510(k) Data Aggregation

    K Number
    K071943
    Device Name
    SERENITY PRO PSF SYSTEM
    Manufacturer
    INOLASE 2002, LTD.
    Date Cleared
    2007-08-10

    (28 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INOLASE 2002, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serenity Pro PSF™ System is an accessory for a compatible leqally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.
    Device Description
    The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 400-700 mbar. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment ervthema.
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    K Number
    K062589
    Device Name
    SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
    Manufacturer
    INOLASE 2002, LTD.
    Date Cleared
    2006-11-30

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INOLASE 2002, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.
    Device Description
    The Serenity PSF™ (Pneumatic Skin Flattening) System is a device which has the ability to produce a vacuum at a level of 200-700 mmHg. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PFS system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
    Ask a Question

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