Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Inclusion criteria

• Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
• For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
• General good health confirmed by medical history and skin examination of the treated area
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study
• BMI≤ 30

Exclusion criteria

• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
• Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
• Previous liposuction in the treatment areas
• History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
• Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
• Poor skin quality (i.e., laxity)
• Abdominal wall diastasis or hernia on physical examination
• Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
• Obesity (BMI > 30)
• Childbirth within the last 12 months or women who suckling a child
• Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
• Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
• Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
• Participation in another clinical study
• Previous body contouring treatments in the treatment areas