Solta Medical Announces FDA 510(k) Clearance for New Clear + Brilliant Technology
HAYWARD, Calif., May 6, 2011 /PRNewswire/ -- Solta Medical, Inc. (Nasdaq: SLTM), the pioneer in fractional resurfacing and non-invasive skin tightening and a global market leader in aesthetic skin treatments today announced it has received FDA 510(k) clearance of its new Clear + Brilliant laser aesthetic treatment, which will officially launch at the World Congress of Dermatology in Seoul, Korea on May 25, 2011. Clear + Brilliant, which previously received CE mark, is an effective treatment based on fractional laser technology that is performed in a professional setting.
The launch of Clear + Brilliant creates and defines an entirely new category of laser aesthetic treatments designed to attract younger patients looking to take control of their aging process. Clear + Brilliant provides a new offering for physicians and skin care providers to address evolving consumer needs and expand their patient base. In-depth research with patients and their skin care providers revealed an unmet need in the skin care continuum that lies between over the counter or spa treatments and more aggressive laser offerings such as Fraxel. These consumers would like a more efficacious treatment than their current regimens, but as of yet they do not need the full transformative benefits of a more aggressive laser skin resurfacing procedure. They are looking for a treatment solution that refreshes their skin, providing a more youthful appearance.
“I evaluated Clear + Brilliant in my practice because I liked the concept of a treatment that addresses both preventive skin care, which many of my younger patients demand, as well as maintenance treatments for patients who have undergone more transformative procedures and want them to last longer,” said Dr. Henry Chan of the Hong Kong Laser and Dermatology Centre. “So far my patients are very happy with Clear + Brilliant because it delivers the results they were looking for. The most common improvements are in the tone and texture of the skin, resulting in younger, healthier looking skin.”
The company began shipping the product to customers in certain international markets in April and plans to begin shipments domestically later this month.
"Solta Medical continues to develop safe, innovative anti-aging solutions and with our newest system, Clear + Brilliant, we are able to reach a whole new professional and patient base," said Stephen J. Fanning, Chairman of the Board, President and CEO of Solta Medical, Inc. "With the FDA clearance of our Clear + Brilliant system, we are strengthening our product portfolio and meeting the needs of skin care professionals and their patients. We are excited about the potential of this product to expand our patient base and generate incremental revenue for clinicians and for the Company."
ABOUT SOLTA MEDICAL, INC.
Solta Medical, Inc. is a global leader in the medical aesthetics market providing innovative, safe, and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address a range of skin issues under the industry's four premier brands: Thermage®, Fraxel®, Isolaz®, and CLARO®. Thermage is an innovative, non-invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Isolaz was the first laser or light based system indicated for the treatment of inflammatory acne, comedonal acne, pustular acne, and mild-to-moderate inflammatory acne. CLARO is a personal care acne system that is the first FDA cleared over-the-counter IPL device that uses a powerful combination of both heat and light to clear skin quickly and naturally. Since 2002, approximately one million Thermage, Fraxel and Isolaz procedures have been performed in over 100 countries. For more information about Solta Medical, call 1-877-782-2286 or log on to www.Solta.com.
© 2010 Solta Medical, Inc. All rights reserved. Thermage, Fraxel, Fraxel re:store, Isolaz, Clear+Brilliant, and Solta Medical are trademarks or registered trademarks of Solta Medical, Inc. or its subsidiaries.
SOURCE Solta Medical, Inc.