Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

Inclusion Criteria

• Male or Female, 24 to 60 years of age (inclusive)
• Fitzpatrick Skin Type I - VI (Appendix 3)
• Has visible fat bulges or skin laxity in the abdominal region
• Scheduled to undergo surgery (abdominoplasty).
• Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
• Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period.
• Subject must be able to read, understand and sign the Informed Consent Form.
• Subject must adhere to the follow-up schedule and study instructions.
• Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study.
• Willing to provide histology samples during the surgery from the intended to be harvested areas.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.

Exclusion Criteria

• Participation in a clinical trial of another device or drug in the target area during the study period.
• Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
• Any prior invasive cosmetic surgery to the target area, such as liposuction.
• Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
• Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
• Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
• Diagnosed or documented immune system disorders.
• History of any disease or condition that could impair wound healing.
• History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
• History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing in the treatment area.
• Infection, dermatitis, rash or other skin abnormality in the target area.
• Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
• Pregnant or currently breastfeeding.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.