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510(k) Data Aggregation

    K Number
    K022341
    Device Name
    TERABYTE 2000 HAIR REMOVER
    Manufacturer
    Date Cleared
    2003-01-27

    (193 days)

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

    TERABYTE CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TERABYTE 2000 System is intended for hair removal and permanent hair reduction.
    Device Description
    TERABYTE 2000 Hair Remover delivers pulsed infrared laser light at a wavelength of 810 nm with selectable pulse duration of 5 - 50 ms, and a selectable fluence of 10 -65 J/cm². The laser pulses are capable of generating a maximum pulse repetition frequency of 1 Hz by several arrays of diode lasers located in the handpiece. The complete system consists of a console and handpiece connected to the system by an umbilical. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output the system requires the set up of the touch screen , and concurrent activation of the following : the handpiece skin touch switch, handpiece trigger , and footswitch. The cryogen is splayed from the top of the handpiece to provide active skin cooling. Laser parameters and other system features are controlled from the touch screen on top of the console, which provides an interface to the system computer.
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