Multi-Center Pilot Study of Cutera truSculpt Device

Exclusion Criteria

• •1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
• •2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
• •3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
• •4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
• •5. Has metal implant(s) within the body, such as artificial heart valves.
• •6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
• •7. History of any disease or condition that could impair wound healing.
• •8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
• •9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
• •10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
• •11. Allergy or sensitivity to Tegaderm.
• •12. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.