InMode Aesthetic Solutions Receives FDA Clearance for the New BodyFX Device

Posted By American Med Spa Association, Thursday, February 12, 2015

Aesthetics company, InMode Aesthetic Solutions announced the Food and Drug Administration’s (FDA) clearance for their latest body contouring applicator, BodyFX. “This new technology, now available for U.S. consumers, uses a three part mechanism and InMode’s A.C.E. (Acquire, Control, Extend) principles to effectively and safely reduce cellulite,” stated Brian Lodwig, President of InMode. “More than 100 noteworthy U.S. physicians and the country’s top qualified centers of excellence have been participating in ongoing IRB clinical trials with impressive results using BodyFX.” It’s the combination of negative pressure, the application of RF (radio-frequency) energy and high efficiency pulses that achieve the results presented in numerous peer-reviewed journals. This triple effect when applied 1x per week showed 68% percent improvement on cellulite for the average patient. Results presented on a clinical trial of patients by Toronto cosmetic plastic surgeon Dr. Stephen Mulholland during a 3 month study showed an average circumferential reduction of 3.58 cm with no non-responding patients. “The cutting-edge technology behind BodyFX offers patients a non-surgical option for getting rid of unwanted fat fast and without the bruising of traditional surgery,” stated Dr. Stephen Mulholland. “For doctors, the technology allows you to achieve precise thermal temperature without the concern of overheating.” Based on extensive research and InMode’s A.C.E. principals of excellence used to develop their cutting-edge technology, the company has become a global leader and favorite of clinicians, consumers, celebrities and beauty experts alike. The BodyFX platform uses time-tested and evaluated radio-frequency energy for precise and optimal heating of the skin. The new platform introduces upgraded features designed to significantly reduce the number of treatments while increasing the efficacy and safety of the procedures. New features include sophisticated temperature monitoring for maximum results, smart controls with automatic cut-offs for unprecedented safety and a vacuum suction that penetrates to address deeper layers of fat tissue. “At InMode, we have made it our mission to assess the needs of consumers and physicians and implement that knowledge in the development of every new product,” commented InMode CEO Moshe Mizrahy. “BodyFX is a truly remarkable device that has the capability of achieving consistent outcomes with minimal discomfort, both of which are important for patients and doctors.” The BodyFX is the most recent to receive U.S. clearance and joins the numerous non-invasive InMode All-In-One comprehensive system. The hand pieces, BodyFX, Fractora, Forma, Lumecca and Diolaze are various modalities of the most diversified system created to offer easy, non-invasive solutions to address a rainbow of beauty and aesthetic concerns in one machine. BodyFX has already received approval in Canada, Europe, Australia and areas of Asia. BodyFX is cleared for the temporary reduction of cellulite. The clearance for the non-invasive device also includes treatment to relieve minor muscle aches and pain and temporary improvement of blood circulation. For more information on the BodyFX and InMode Aesthetic Solutions, visit