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510(k) Data Aggregation

    K Number
    K243035
    Device Name
    Ulthera® System
    Manufacturer
    Ulthera, Inc.
    Date Cleared
    2025-02-24

    (150 days)

    Product Code
    OHV, IYO
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ulthera, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: - Lift the eyebrow - Lift lax submental (beneath the chin) and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions - Improve lines and wrinkles of the décolleté - Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: - Ensure proper coupling of the transducer to the skin - Confirm appropriate depth of treatment such as to avoid bone
    Device Description
    The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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    K Number
    K233996
    Device Name
    Ulthera System (UC-1 Control Unit PRIME)
    Manufacturer
    Ulthera, Inc.
    Date Cleared
    2024-02-22

    (66 days)

    Product Code
    OHV
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ulthera, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: · Lift the eyebrow • Lift lax submental (beneath the chin) and neck tissue. which can also affect the appearance of lax tissue in the submental and neck regions · Improve lines and wrinkles of the décolleté The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: · Ensure proper coupling of the transducer to the skin - · Confirm appropriate depth of treatment such as to avoid bone
    Device Description
    The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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    K Number
    K192185
    Device Name
    The Cellfina System
    Manufacturer
    Ulthera, Inc
    Date Cleared
    2019-10-09

    (58 days)

    Product Code
    OUP
    Regulation Number
    878.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ulthera, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation.
    Device Description
    The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
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    K Number
    K180623
    Device Name
    Ulthera System
    Manufacturer
    Ulthera, Inc
    Date Cleared
    2018-05-04

    (56 days)

    Product Code
    OHV, IYO
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ulthera, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: · lift the eyebrow • Ift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions · improve lines and wrinkles of the décolleté The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The inaging is to visualize the dermal and subdermal layers of tissue to: · ensure proper coupling of the transducer to the skin · confirm appropriate depth of treatment such as to avoid bone
    Device Description
    The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.
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    K Number
    K161885
    Device Name
    The Cellfina System
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2016-10-05

    (86 days)

    Product Code
    OUP
    Regulation Number
    878.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 3 years of observation.
    Device Description
    The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 50-use motor module (CM1).
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    K Number
    K153677
    Device Name
    The Cellfina System
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2016-02-25

    (66 days)

    Product Code
    OUP
    Regulation Number
    878.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation.
    Device Description
    The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1).
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    K Number
    K150505
    Device Name
    Cellfina System
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2015-07-29

    (154 days)

    Product Code
    OUP
    Regulation Number
    878.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 vears of observation.
    Device Description
    The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The release of subcutaneous tissue for improvement in the appearance of cellulite is a minimally invasive surgical technique by physicians using of manual surgical instruments and accessories. The Cellfina device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the tissue release. The system consists of a sterile single use disposable kit and a non-sterile reusable motor module.
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    K Number
    K134032
    Device Name
    ULTHERA SYSTEM
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2014-06-20

    (171 days)

    Product Code
    OHV, IYO
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: - lift the eyebrow - lift lax submental (beneath the chin) and neck tissue - improve lines and wrinkles of the décolleté The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal layers of tissue to: - ensure proper coupling of the transducer to the skin - confirm appropriate depth of treatment such as to avoid bone
    Device Description
    The Ulthera® System consists of the following components: • Ulthera® Control Unit • Handpiece • Transducers
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    K Number
    K132028
    Device Name
    ULTHERA SYSTEM
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2013-12-11

    (163 days)

    Product Code
    OHV, IYO
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: - lift the eyebrow . - lift lax submental (beneath the chin) and neck tissue . The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: - . ensure proper coupling of the transducer to the skin - confirm appropriate depth of treatment such as to avoid bone .
    Device Description
    The Ulthera System consists of the following components: - . Ulthera Control Unit - Handpiece . - Transducers .
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    K Number
    K121700
    Device Name
    ULTHERA SYSTEM
    Manufacturer
    ULTHERA, INC.
    Date Cleared
    2012-10-02

    (117 days)

    Product Code
    OHV
    Regulation Number
    878.4590
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTHERA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: - lift the eyebrow . - lift lax submental (beneath the chin) and neck tissue .
    Device Description
    The Ulthera System consists of the following components: Ulthera® Control Unit . Handpiece . . Transducers
    Ask a Question

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