The clearance will enable the medical device company to expand its sales and marketing activities in the country.
FREMONT, CA: SofWave Medical is an emerging aesthetic device company which has been making waves in the sector. It was recently conferred with a 510(k) clearance by the US Food and Drug Administration (FDA) for its SofWave System. The device is designed for non-invasive aesthetic treatment to reduce facial lines and wrinkles. A blinded study of 59 subjects demonstrated the safety and performance of the SofWave System. The outcomes spurred the FDA clearance for the device.
The trial was led by principal investigators Dr. Roy Geronemus and Dr. Arielle Kauvar. The evaluation revealed that the device enhanced wrinkle appearance of at least one Elastosis Score (-1ES) in 86 percent of the subjects. The blinded reviewers identified the pre and post-treatment photographs correctly for 78 percent of the treated subjects.
Louis Scafuri, CEO of SofWave, said, "Receiving FDA clearance for the SofWave technology is an important milestone for the company as it opens our product to the large market in the United States. Our breakthrough non-invasive ultrasound technology targets a growing customer base of patients who are looking to reduce their wrinkles and facial lines but did not wish to consider surgery. We believe that our device addresses this demand across broad demographics."
SofWave specializes in the development of novel approaches for wrinkle reduction, leveraging the proprietary Fractional Ultrasound. The breakthrough technology of SofWave brings a new option to non-invasive aesthetic treatments, equipping physicians with smart, simple, effective, and safe aesthetic solutions for their patients. Founded by a multidisciplinary team of engineers, physicists, and aesthetic professionals in the year 2015, SofWave has its corporate, R&D, and manufacturing headquarters in Israel, and several offices in California.
The FDA's 510(k) clearance will enable the company to launch its marketing and sales activities in the US. SofWave has opened a new office in the US, which will serve as a base for all sales, marketing, clinical, and customer support activities.
Dr. Roy Geronemus said, "The Sofwave technology represents the next-generation in aesthetic devices and is exactly what my patients are looking for – non-invasive, minimal downtime, and with favorable results. The Sofwave device has great potential to fill this void."
Dr. Kauvar said, "Our patients were surprised they could achieve such obvious results after only one treatment. The Sofwave procedure is tolerated very well, and it appears that the treatment depth is ideal for improving aging skin."
Dr. Shimon Eckhouse, Sofwave Medical's Chairman of the Board, stated, "Our patented, low-divergence fractional ultrasound technology is a simple solution based on sophisticated science with proven efficacy to treat facial lines and wrinkles. I am excited to once again bring innovative aesthetic devices to the market."
SofWave's technology enables the enhancement of lines and wrinkles on the face, neck, and chest. It facilitates further options for individuals looking to avoid surgery for facial augmentation. The low divergence ultrasound device is non-surgical, offers minimal downtime, and delivers measurable results.