UltraShape Power in Combination With U-sculpt-n Transducer
UltraShape Power in Combination With U-sculpt-n Transducer
Prospective, open label, self - controlled, single arm, clinical study to assess the
 performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for
 circumference reduction versus self-control.
Inclusion Criteria:

 1. Subject ≥18 and ≤60 years of age at the time of enrollment

 2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by
 calibrated caliper)

 3. For women of child-bearing potential: negative urine pregnancy test

 4. General good health confirmed by medical history and skin examination of the treated
 area

 5. Subject understands the study requirements and the treatment procedures and provides
 written Informed Consent before any study-specific tests or procedures are performed.

 Exclusion Criteria:

 1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease,
 congestive heart failure, pacemaker/defibrillator

 2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive
 status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue
 disease

 3. Having a permanent implant in the treated area, such as metal plates, or an injected
 chemical substance such as silicone

 4. Previous liposuction in the treatment areas within 12 months

 5. History of skin disease in the treatment area, known tendency to form keloids or poor
 wound healing

 6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count
 within the last 3 months

 7. Childbirth within the last 12 months or women who are breastfeeding a child