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510(k) Data Aggregation

    K Number
    K223110
    Device Name
    truSculpt iD
    Manufacturer
    Date Cleared
    2022-11-03

    (31 days)

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

    Cutera Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation. Additionally, the 2MHz setting for the 40 cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.
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    K Number
    K221407
    Device Name
    truSculpt iD
    Manufacturer
    Date Cleared
    2022-07-13

    (58 days)

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

    Cutera Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The truSculpt iD device is intended to generate heat within body tissues for the treatment of selected medical conditions, such as the relief of minor aches, pain, and muscle spasms; an increase in local circulation; a reduction in circumference of the abdomen; and non-invasive lipolysis (breakdown of fat) of the abdomen. The truGlide roller is intended to provide temporary reduction in the appearance of cellulite. The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation. Additionally, the 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The truSculpt iD device consists of a console, one or more RF handpieces that connect to the console with umbilical cables, and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. The truGlide is a separate mechanical roller that can be used as a massager.
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    Ask a specific question about this device

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