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510(k) Data Aggregation

    K Number
    K073659
    Device Name
    XTRAC ULTRA 2, MODEL AL10000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2008-03-05

    (70 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
    Device Description
    The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
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    K Number
    K051428
    Device Name
    VTRAC EXCIMER LAMP SYSTEM
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2005-08-09

    (69 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.
    Device Description
    The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.
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    K Number
    K041943
    Device Name
    XTRAC XL, MODEL AL8000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2004-10-14

    (87 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
    Device Description
    The XTRAC XL2 Excimer Laser System Model AL8000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic operater services ann. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
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    K Number
    K031451
    Device Name
    XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2003-08-01

    (86 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
    Device Description
    The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.
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    K Number
    K020847
    Device Name
    XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2002-05-16

    (62 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
    Device Description
    The XTRAC Excimer Laser System is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate an operator selected doseand target-specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a footswitch. The laser is enclosed in a protective interlocked housing.
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    K Number
    K011382
    Device Name
    XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2001-08-02

    (87 days)

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

    PHOTO MEDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003705
    Device Name
    XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
    Manufacturer
    PHOTO MEDEX, INC.
    Date Cleared
    2001-03-01

    (90 days)

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

    PHOTO MEDEX, INC.

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

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