Sciton's Hybrid Fractional Device for Women's Health Receives FDA Tool Clearance

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Sep 08, 2022, 09:00 ET

The Gynecological Tool diVa Now Available to Women's Health Providers in the US

PALO ALTO, Calif., Sept. 8, 2022 /PRNewswire/ -- Sciton Inc., a leading manufacturer of medical and aesthetic lasers and light sources, proudly announces the 510K FDA tool clearance received on July 16 for their diVa handpiece. The FDA's tool clearance will allow Sciton to continue to provide women's health practitioners with an established skin resurfacing tool for feminine health.

"Sciton is proud to help practitioners address women's health with the diVa tool. For the past six years, we've focused on how to impact women's lives aesthetically, emotionally, and physically. diVa is one of the tools Sciton is passionate about to help practitioners do just that," says Amy Bomberg, Sciton's Strategic Market Manager for Women's Health.

Utilizing Sciton's proven hybrid fractional technology, first developed for HALO®, the diVa handpiece is used in treatments that resurface soft tissue in 3 to 5 minutes. The diVa tool delivers both ablative and non-ablative wavelengths to the same microscopic treatment zone, providing tunable, independent levels of ablation and custom settings based on the patient's symptoms. Patients can enjoy normal daily activities immediately after, and there is typically no heavy or time-intensive post-care.

The diVa handpiece is offered on the JOULE® multi-application platform. Configurable with an array of award-winning laser and light-based technologies, JOULE enables providers to perform aesthetic, surgical, and gynecological procedures with one powerhouse system.

"At Sciton, we aren't afraid to swim against the current. We take the time to work with the FDA to bring the most innovative products to market while using our quality craftsmanship to build systems that last. The result is a long-term and successful partnership with our customers," Aaron Burton, Sciton's CEO, says.

Sciton is committed to working closely with the FDA to provide practitioners with the safest and most efficacious technology to successfully address women's health.

For more information about diVa, please visit https://sciton.com/diva-laser/.

ABOUT SCITON

Sciton, Inc., located in Palo Alto, California, is a 100% employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance, and value. Sciton offers aesthetic and medical devices for women's health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates worldwide with direct sales in the United States, Canada, Japan, Australia, and distributor partners in more than 45 countries. For more information and a complete listing of Sciton systems, visit sciton.com.

SOURCE Sciton, Inc.