Radiofrequency and Targeted Pressure Energy for Cellulite Reduction

This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.

Inclusion Criteria:Voluntarily signed informed consent formAge ≥ 21 yearsSubject suffer from Grade 2 or Grade 3 cellulite as per Nürnberger-Muller ScaleSubject did not experience weight change exceeding 2.5 kg (5 lb) in the preceding monthBMI ≤ 33 kg/m2Women of childbearing potential are required to use birth control measures during the whole duration of the studySubjects willing and able to abstain from partaking in any treatments other than the study procedure to promote skin tightening and cellulite reduction during study participationSubjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participationExclusion Criteria:Bacterial or viral infection, acute inflammationsImpaired immune systemAutoimmune diseaseDiabetesHerpes SimplexIsotretinoin in the past 12 monthsSclerodermaRadiation therapyBurns in the treatment areaPoor healing in the treatment areaMetal implantsImplantable pacemaker or automatic defibrillator / cardioverterAblative / non-ablative cosmetic intervention (deep peeling) in the past 3 monthsCancer and tumor diseasesActive collagen diseasesCardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)Pregnancy / nursing or IVF procedureAcute neuralgia and neuropathyBlood disorders, risk of bleeding, bleeding tissues, peptic ulcersEczemaRosaceaFebrile conditionsKidney or liver failurePronounced edemas, ascites, exudatesSensitivity disorders in the treatment areaVaricose veinsLocal corticosteroid therapy