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    K Number
    K022568
    Device Name
    PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-08-29

    (27 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ProLite / Plasmalite MPX Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.

    Device Description

    The ProLite / Plasmalite MPX Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

    AI/ML Overview

    The provided text does not contain any information regarding acceptance criteria or a study proving device performance.

    The document is a 510(k) summary for the ProLite / Plasmalite MPX Pulsed Light System. It states that "Performance Data: None" and concludes that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for removal of unwanted hair in all skin types according to the Fitzpatrick Scale."

    Therefore, I cannot provide the requested information.

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