US FDA Clearances

Emsculpt Neo® is intended for non-invasive lipolysis (breakdown of fat) of the abdomen and thighs and reduction in circumference of the abdomen and thighs with Skin Type I to Skin Type III. Emsculpt Neo® is also cleared for improvement of abdominal tone, strengthening of the abdominal muscles and development of firmer abdomen. Strengthening, toning, firming of buttocks, thighs, and calves. Improvement of muscle tone and firmness, for strengthening muscles in arms. 1Abdominal toning and  reduction of  subcutaneous fat with combination of novel radiofrequency treatment and HIFEM procedure - MRI scan study. Jacob C. et al. Presented at ASDS 2020 Virtual Meeting. 2Radiofrequency heating and HIFEM delivered simultaneously - the first sham-controlled randomized trial. Katz B.  et  al. Presented at ASDS 2020 Virtual Meeting. 3Ultrasound evaluation of the simultaneous RF and HIFEM treatments on human fat tissue. Denkova R. Source: U.S. Food and Drug Administration. 510(k) Premarket Notification: K192224. Published online on December 5, 2019. 4Halaas Y, Duncan D, Bernardy J, Ondrackova P, Dinev I. Activation of Skeletal Muscle Satellite Cells by a Device Simultaneously Applying High-Intensity Focused Electromagnetic Technology and Novel RF Technology: Fluorescent Microscopy Facilitated Detection of NCAM/CD56. Aesthet Surg J. 2021.  Emsculpt® is intended for improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of buttocks,  thighs, and calves. Improvement of muscle tone and firmness, for strengthening muscles in arms. Emtone™ is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. EMTONE massage device is intended to provide a temporary reduction in the appearance of cellulite. Exilis Ultra 360™ is intended for use in non-invasive dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids, to provide a temporary reduction in the appearance of cellulite, and to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain and increase in local circulation. BTL Emsella® is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence. BTL Vanquish ME™ is indicated for temporary reduction in the circumference of the abdomen and thighs. BTL®, EMSCULPT NEO®, EMSCULPT®, EMSELLA®, Exilis®, HIFEM®, Vanquish® are registered trademarks in the United States of America, the European Union and/or other countries. Trademarks EMSCULPT NEO®, EMSCULPT®, EMSELLA®, EMTONE™, EM™ and HIFEM® are parts of EM Family of products. * Data on file. ** Results and patient experience may vary. As with any medical procedure, ask your doctor if the procedure is right for you. Patient names have been changed for their privacy. These products, the methods of manufacture or the use may be subject to one or more U.S. or foreign patents or pending applications. For more information click here.