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Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.

Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.

Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation.

Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook next to fibrous septa captures the septa resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the fibrous septa. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all contributing septa have been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression.

Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.

Avéli is a sterile, single-use manual instrument that cuts fibrous tissue (septa) beneath moderate to severe cellulite for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a handle and a distal end. The handle houses components used to actuate the moving parts at the distal end of the device. The distal end of the device is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The distal end of the device contains a blunt link and a sharpened link forming a distal hook. When the handle is moved in a retrograde fashion, the distal hook next to a fibrous septum captures the septum resulting in tugging. The user feels the resistance, confirming that a septum under a cellulite depression has been identified. The user then engages a sharpened link to be exposed at the distal end of the device. The user applies additional retrograde motion to sever the fibrous septum, and then retracts the sharpened link and the blunt link into the device, allowing removal without further tissue capture. The step is repeated for each visible cellulite depression.

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.

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).

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.

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).

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.

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).

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.

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.

The Cabochon 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 1 year of observation.

The Cabochon System is the same (identical) device as the legally marketed predicate and 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 a variety of manual surgical instruments and accessories. The Cabochon device consists of a powered cutting blade and a means for instrument guidance to control the depth, size and shape of the area of the tissue release.

The Cabochon System is intended for the short-term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females.

The Cabochon System temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples. The release of subcutaneous tissue for improvement in the appearance of cellulite is a surgical technique currently performed by physicians using a variety of manual surgical instruments. The depth and specific area of release achieved with the manual surgical instruments are generally variable and user-dependent. The Cabochon System has been designed to provide added control over both the depth and area of release.