FDA Closes Inquiry Regarding IHCTOA Letter Regarding Sciton's diVa® Laser
PALO ALTO, Calif., Nov. 21, 2018 /PRNewswire/ -- Sciton, Inc. announced today that the FDA has advised the company that it appears that Sciton has satisfactorily addressed all items raised by the FDA in its July 24, 2018 "It Has Come to Our Attention" letter. Sciton worked with the FDA in a transparent and collaborative manner to resolve all concerns and will continue to review its marketing and promotional materials to assure full compliance with all FDA guidelines and regulations.
"We are pleased that the FDA has accepted our response in full, and we remain passionate about continuing to develop impactful and innovative laser products that significantly advance women's health in the areas of urogynecology and gynecology," said Daniel K. Negus, PhD, President of Sciton, Inc.
diVa operates on the JOULE(TM) platform which has long been FDA-cleared for coagulation and ablation of soft tissue, including gynecologic and mucosal tissue. Sciton is committed to further research and study of the capabilities of diVa in urogynecology. We remain extraordinarily committed to supporting the continued advancement of this important area of Women's Health with diVa and are excited to move forward.
ABOUT diVa
diVa expands the broad range of Sciton's JOULE(TM) platform capabilities to address a woman's most intimate wellness. diVa is the only device available that includes HPA (High Precision Automation) technology to ensure the safest and best treatment outcomes for patients and predictability for the operator. Additionally, diVa's dual-wavelength hybrid technology and tunability allows operators to customize treatments based on a patient's age, symptoms, and desired results.
ABOUT SCITON, INC.
Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance and value.
Sciton offers medical and aesthetic devices to treat women's health conditions, vascular lesions, pigmentation, skin texture and tone, scar reduction, acne, laser assisted lipolysis, fractional and full coverage skin resurfacing, phototherapy, wrinkle reduction and hair reduction. Sciton operates on a worldwide basis with direct sales forces in the United States, Canada, Japan and distributor partners in more than 45 countries. For more information, and a complete listing of Sciton systems, visit www.sciton.com.
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SOURCE Sciton, Inc.
