Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration

Exclusion Criteria

• •1. Children and adolescents (less than 18 years old).
• •2. Subjects who are not willing or able to provide written consent.
• •3. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
• •4. Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
• •5. Subjects with known blood coagulopathies.
• •6. Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease).
• •7. Subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks.
• •8. Subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks.
• •9. Subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product.
• •10. Subjects with open wounds in the area of ultrasound treatment.
• •11. Subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment.
• •12. Female patients who are planning a pregnancy, currently pregnant or nursing.