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510(k) Data Aggregation

    K Number
    K013707
    Device Name
    SOFTIQUE, MODEL GI 11001
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    2002-02-01

    (85 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TV CONCEPTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses: 1. Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation 2. Relaxes muscles, relieves stiffness and muscle spasm 3. Stimulates circulation and for other conditions where heat is indicated
    Device Description
    The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.
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    K Number
    K973174
    Device Name
    SONIQUE HAIR REMOVER
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    1997-10-30

    (66 days)

    Product Code
    KCX
    Regulation Number
    878.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TV CONCEPTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the removal of hair
    Device Description
    The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
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    K Number
    K973179
    Device Name
    FEMINIQUE SONIC HAIR REMOVER
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    1997-10-30

    (66 days)

    Product Code
    KCX
    Regulation Number
    878.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TV CONCEPTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the removal of hair
    Device Description
    The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
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