Sam Brusco, Associate Editor01.02.24
Sofwave Medical, a company focused on energy-based, non-invasive, aesthetic devices, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for improvement of the appearance of skin laxity on the upper arms.
The new clearance, the company said, paves the way for Sofwave to expand into additional treatment indications.
Louis Scafuri, Sofwave CEO, said, “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.”
Sofwave’s SUPERB platform introduces a viable, FDA-cleared, non-invasive alternative to improve the appearance of skin laxity on the upper arms without the associated risks and recovery time of conventional surgery, laser-based body contouring, and other minimally invasive procedures.
In the U.S., Sofwave’s tech is currently cleared for non-invasive aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars.
The new clearance, the company said, paves the way for Sofwave to expand into additional treatment indications.
Louis Scafuri, Sofwave CEO, said, “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.”
Sofwave’s SUPERB platform introduces a viable, FDA-cleared, non-invasive alternative to improve the appearance of skin laxity on the upper arms without the associated risks and recovery time of conventional surgery, laser-based body contouring, and other minimally invasive procedures.
In the U.S., Sofwave’s tech is currently cleared for non-invasive aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars.