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510(k) Data Aggregation

    K Number
    K052371
    Device Name
    DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
    Date Cleared
    2006-05-04

    (247 days)

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

    HAIR INTERNATIONAL SYSTEMS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Depilite EL-8b DERMO FLASH TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. The Depilite EL-8b DERMO FLASH TM Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
    Device Description
    The Depilite EL-8b Series DERMO FLASH™ devices are microprocessorcontrolled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual.
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