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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.