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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

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.

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

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.

The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite. The Pure Impact module is indicated to be used for: · Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. · Strengthening, toning and firming of buttocks and thighs.

The SofMave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofMave System consists of three main functional components: 1) console; 2) applicator; and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

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

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.

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofWave System consists of two main functional components: 1) the console, and 2) the applicator. The console includes the power sources, cooling unit, electrical components, loT, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite. The Pure Impact module is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, toning and firming of buttocks and thighs.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, IoT, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The subject device of this 510(k) adds an EMS module ("Pure Impact") to the previously cleared SofWave ultrasound system (K230820). The EMS module is wirelessly connected to and controlled by the SoftWave console. It functions independently from the existing ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

The SCIZER delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue(SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The SCIZER is specifically indicated for non-invasive waist circumference reduction.

The Subject Device consists of 2 handpieces, a control unit, a Touch LCD monitor, power supply unit for irradiation and for setting parameters after the main power and key switch is turned on. HIFU energy is irradiated based on a linear scanning method through the handpiece depending on irradiation energy that is set in advance by the user. The Cartridge D13 used with the Subject Device focuses the HIFU energy from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. The Cartridge can treat a region of tissue up to 46mm long and 46mm wide. The Cartridge can apply a maximum of 24 lines at a time. As a result, tissue temperature rises over 56°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in the destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response. Immediately before the procedure, purified water was applied to the treatment area to promote the desired energy transmission of the ultrasound transducer. To minimize the pain from the thermal HIFU procedure, the cooling level was used through the GUI. It is recommended to use an ultrasound imaging system to visualize the sub-dermal regions of interest before treatment. It allows the physician to compile a precise view of the target treatment area.

The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.

The BeShape One™ device is a non-invasive, high intensity, non-focused US device intended for disruption of the subcutaneous adipose tissue and indicated for noninvasive waist circumference reduction. The BeShape One™ device utilizes continuous wave (CW) ultrasonic energy applied to the adipose tissue at a temperature of 47-49ºC. A cooling system maintains the skin temperature at below 35℃. The device consists of hardware and software. These elements are integrated in the BeShape One™ console and applicator/hand piece. BeShape One™ is supplied as a console and two identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: - Power Source - Controller unit (CPU) . - Water cooling system (Chiller) ● - Vacuum System - . Block Amplifier - Touchscreen display monitor ● - Personal computer and proprietary software . - Two designated applicator cradles . - Two designated applicator connector ports . The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements: - Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz. - . Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator. - The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C. The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.

The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofMave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, the loT and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.