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510(k) Data Aggregation

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

    (193 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TERABYTE 2000 System is intended for hair removal and permanent hair reduction. The TERABYTE 2000 System is intended for use on all skin types (Fitzpatrick Skin Types ) , including tan skin. The device is intended for prescription use.

    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.

    AI/ML Overview

    The provided document states that no performance data was required or submitted for the TERABYTE 2000 Hair Remover.

    The rationale given is: "The specifications and indications for use of the TERABYTE 2000 System are the same or very similar to those of the claimed predicate devices. The TERABYTE 2000 System has the same or very similar indications for which the claimed predicates have been cleared. Because of this, performance data were not required."

    Therefore, I cannot provide the requested information as it is not present in the given text. All sections of your request (acceptance criteria, study details, sample sizes, ground truth method, MRMC study, standalone performance, training set details) are dependent on the existence of performance data, which was explicitly stated as "None."

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