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Solta Medical Reports FDA Clearance Received for Second Generation LipoSonix® System
Date:10/24/2011

nology was developed over a period of 10 years by leading scientists and ultrasound experts with more than 200 years of combined experience in the development of therapeutic and diagnostic ultrasound devices.

The LipoSonix system uses advanced high–intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat just beneath the skin in the treatment areas of the abdomen and flanks as a noninvasive, nonsurgical approach to aesthetic waist circumference reduction. Clinical studies conducted by Medicis Technologies Corporation showed an average waist circumference reduction of approximately 2.6 cm after a single treatment with the LipoSonix system. Office visit time and individual results may vary. Results are typically seen in 8 to 12 weeks.

The LipoSonix treatment is not a replacement for liposuction surgery or a healthy lifestyle, or a way to lose weight. No special diet or exercise program is required. The LipoSonix system has a well–defined safety profile. There is no need for anesthesia.

Important Safety Information for the LipoSonix System

The LipoSonix treatment may pose certain risks and may not be suitable for everyone. The LipoSonix system is intended for adults over 18 years of age who have at least 1.0 cm of fat thickness beyond the selected treatment focal depth of the system in the area to be treated. The most frequently reported side effects during the LipoSonix treatment are: discomfort, pain, cold, prickling, tingling or warmth. The most frequently reported side effects after the LipoSonix treatment, when used as recommended, are: pain (discomfort), bruising, redness and swelling, which are generally described (or rated) as mild. You should not have the LipoSonix treatment if you are pregnant or think you may be pregnant. The LipoSonix treatment is available only from a qualified healthcare professional.

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