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InMode Receives Notice from the FDA of Satisfactory Address of the FDA Letter
LAKE FOREST, Calif. and YOKNEAM, Israel, Nov. 26, 2018 (GLOBE NEWSWIRE) -- InMode Ltd. announced today that the FDA has advised the company of satisfactory address of all items that appeared in the ‘It Has Come to Our Attention’ letter.
On July 24th 2018, InMode, along with many other aesthetic laser companies, received an “It Has Come to Our Attention” letter. InMode has been communicating with the FDA to specify all FDA clearances and listings of the Votiva platform, and on November 9th 2018, InMode received notice stating that: “FDA determined that it appears your firm has addressed all items found in the ‘It Has Come to Our Attention’ letter.”
InMode is committed to work in full collaboration with the FDA and, as discussed with FDA, will continue to review its marketing and promotional material to assure full compliance with the FDA clearances and listings for the Votiva platform, and any other platforms marketed by InMode.
“We are pleased that the FDA has accepted our response in full. We will continue to market our Votiva platforms in accordance with FDA guidelines and regulations, and in accordance with the Votiva platform clearances and listings. InMode will continue to develop products for the rapidly-growing women’s health and wellness market,” said Shakil Lakhani, President of InMode, North America.
InMode is a leading global provider of innovative, energy-based, minimally and non-invasive aesthetic solutions. InMode has developed and commercialized products utilizing medically-accepted radiofrequency energy technology, which can penetrate deep into the subdermal fat, allowing adipose tissue remodelling. InMode’s technologies are used by physicians to remodel subdermal adipose, or fatty tissue, in a variety of procedures including liposuction with simultaneous skin tightening, face and body contouring, ablative skin treatments and women’s health and wellness procedures. Learn more about InMode technologies by visiting www.inmodemd.com.
Amanda Reinstein / Behrman Communications