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    K Number
    K063748
    Device Name
    THERMOMED 1.8
    Manufacturer
    THERMOSURGERY TECHNOLOGIES, INC.
    Date Cleared
    2007-02-01

    (44 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOSURGERY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
    Device Description
    The ThermoMed Model 1.8 is a battery-operated device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue.
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    K Number
    K021117
    Device Name
    TTI THERMOMED MODEL 1.8 INSTRUMENT
    Manufacturer
    THERMOSURGERY TECHNOLOGIES, INC.
    Date Cleared
    2002-05-02

    (24 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOSURGERY TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TTI ThermoMed™ Model 1.8 Instrument provides the therapeutic modality to treat the following benign diseases and conditions: 1. Warts 2. Molluscum Contagiosum 3. Anqioma 4. Fibroma 5. Seborrheic Keratoses 6. Acrochordon 7. Syringoma 8. Hydrocystoma 9. Clavus 10. Actinic Keratoses 11. Keloids 12. Epidermoid Cysts 13. Cystic Acne 14. Cutaneous Leishmaniasis 15. Atypical Mycobacteria 16. Dermatophytosis
    Device Description
    The TTI ThermoMed device delivers controlled localized current field (LCF) radio frequency (RF) heat to selectively destroy certain diseased tissue. RF energy is delivered to the dermal surface via a hand held wand with an autoclaveable energy applicator. For convenience, an audial and visual signal indicates the elapsed treatment time in 30-second intervals after the selected target temperature is reached.
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