SAN CLEMENTE, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission for the improvement of the appearance of skin laxity on the upper arms and paves the way for Sofwave™ to further expand into additional treatment indications.
Mr. Louis Scafuri, Sofwave CEO, commented: “We are pleased to receive FDA clearance for improvement of the appearance of skin laxity on the upper arms in the U.S. supported by compelling clinical study results. Lax skin on the upper arms is a prevalent issue that can impact individuals not only from a physical appearance aspect but also emotionally. Whether the presence of sagging or loose skin on their upper arms is a result of aging, weight loss, genetics, or a combination of factors, the results of our upper arm laxity study provide a clear, objective clinical data set and patient outcomes further advancing our progress to become the leading provider of choice in the growing non-invasive medical aesthetic industry. We look forward to continuing to expand the use of our innovative technology to other aesthetic treatment applications throughout the body.”