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510(k) Data Aggregation

    K Number
    K023081
    Device Name
    PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-12-16

    (90 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProLite / Plasmalite MPX Pulsed Light System is indicated to permanently reduce unwanted hair. The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.
    Device Description
    The ProLite / PlasmaliteMPX 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
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    K Number
    K022378
    Device Name
    PLASMALITE PULSED LIGHT SYSTEM
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-10-18

    (88 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plasmalite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
    Device Description
    The Plasmalite 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
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K022569
    Device Name
    PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-08-29

    (27 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.
    Device Description
    The Prolite / Plasmalite MPX Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
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    K Number
    K013365
    Device Name
    PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-01-08

    (90 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos.
    Device Description
    The ProLite Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
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    K Number
    K013366
    Device Name
    PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2002-01-08

    (90 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProLite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
    Device Description
    The ProLite 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 sypply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
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    K Number
    K010927
    Device Name
    MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2001-06-19

    (83 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010928
    Device Name
    PROLITE VL PULSED LIGHT SYSTEM
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2001-06-19

    (83 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000929
    Device Name
    PROLITE PULSED LIGHT SYSTEM
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2000-10-17

    (209 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002072
    Device Name
    PROLITE VL PULSED LIGHT SYSTEM
    Manufacturer
    MEDICAL BIO CARE SWEDEN AB
    Date Cleared
    2000-09-11

    (66 days)

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

    MEDICAL BIO CARE SWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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