This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and improvement in skin quality. Subjects will receive two RF treatments (performed 4 to 6 weeks apart) with the Cutera truSculpt™ radiofrequency (RF) device. Subjects will return to the site after study treatments have been delivered for two follow-up visits: 4 weeks (± 2 week) and 12 weeks (± 2 week) post-final treatment.~Primary Efficacy Endpoint as the correct Identification of 12 weeks post final treatment photographs from baseline as assessed by two of the three blinded assessors in at least 75% of the patients, and an improvement of ≥ 1 point on the Fitzpatrick Wrinkle Classification System (FWCS.)~Secondary Efficacy Endpoints as the:~Principal Investigator's assessment of improvement at 12 weeks post-final treatment (Physician's Global Assessment.)~Principal Investigator's assessment of improvement at 12 weeks post-final treatment using the Alexiades Scale.~Subject satisfaction level at 12 weeks post-treatment~Safety Endpoint as the incidence and severity of adverse events during the study period and at follow ups.
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.