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510(k) Data Aggregation

    K Number
    K033933
    Device Name
    POWERLITE 600 EX SYSTEM
    Manufacturer
    Date Cleared
    2004-03-16

    (88 days)

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

    PRESWEDE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An intense pulsed light, the Powerlite 600® EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoaqulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows: - The treatment of tattoos; . - The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles); - The treatment of cutaneous lesions including warts, scars and striae; . - The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; - The removal of unwanted hair from all skin types, and to effect stable long-term, . or permanent, hair reduction in skin types I-V.
    Device Description
    The Powerlite 600® EX System delivers pulsed light at a wavelength beginning at a wavelength of 515nm. The device consists of three interconnected sections: a light system console (including software and control electronics), a control and display panel; and one or more attached hand-piece(s).
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    K Number
    K030423
    Device Name
    POWERLITE 600 EP SYSTEM
    Manufacturer
    Date Cleared
    2003-05-09

    (88 days)

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

    PRESWEDE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powerlite 600® EP System is used for the removal of unwanted hair.
    Device Description
    The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.
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