Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Inclusion Criteria: * Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 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 and flank 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 and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study, within 5% of baseline weight measurement. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. 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 within 6 months of study participation, or 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 treatmen…