Fraxel® Dual Laser System Receives New FDA 510(k) Clearance For Treatment Of Skin Pigmentation
HAYWARD, Calif., June 20, 2013 /PRNewswire/ — Solta Medical, Inc. (Nasdaq: SLTM), the global market leader in aesthetic skin treatments, today announced it has received a new FDA 510(k) clearance of its Fraxel® DUAL 1550/1927 laser system for the treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
“The Fraxel DUAL 1550/1927 provides patients superior anti-aging results, specifically when treating pigmentation of the skin caused by sun exposure,” said Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York and clinical professor of dermatology at New York University Medical Center. “The additional FDA clearance for Fraxel DUAL is a breakthrough in the treatment, improvement, and correction of undesired skin pigmentation. With the 1927 nm wavelength, patients can see significant results with very little downtime.”
In addition to the treatment of pigmented lesions, the Fraxel DUAL system is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. Specific additional indications include actinic keratosis (AKs), melasma, treatment of periorbital wrinkles, acne scars and surgical scars.
The Fraxel DUAL system is an unsurpassed breakthrough skin resurfacing technology that renews skin and helps maintain skin’s youthful glow despite a person’s age or skin color, with minimal discomfort and downtime. It is a fractional laser system that safely penetrates the skin down to the dermis without disrupting the skin’s protective outer barrier, thus maximizing safety and recovery time. The result is natural stimulation of new collagen creation, which exists naturally in the dermis to provide structural support and gradually breaks down throughout the aging process weakening the skin, leading to fine lines, wrinkles and sagging skin.
“Solta Medical is committed to developing safe, effective treatments to advance the aesthetic industry,” said Stephen J. Fanning, President and CEO of Solta Medical, Inc. “With the additional FDA clearance of our Fraxel DUAL system, we are enhancing the cutting-edge technology offered by our physicians and sought by patients, specifically in treating pigmentation and actinic keratosis caused by sun damage.”
For more information about the Fraxel® DUAL Laser System, please visit http://fraxel.com.
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 aesthetic energy devices for skin resurfacing and rejuvenation, acne reduction, body contouring and skin tightening, as well as tools and accessories to optimize the latest liposuction techniques. Each brand is an established category leader, and together comprise of a comprehensive platform to address a range of aesthetic skin and body issues. Fraxel(®) delivers minimally-invasive clinical solutions to resurface aging and sun damaged skin. Clear + Brilliant(®) is a cost-effective, non-ablative laser treatment uniquely designed to improve skin tone and radiance. Isolaz(®) acne treatment combines vacuum and painless broadband light to address a wide variety of acne types. CLARO(®) is an FDA-cleared personal care acne device that uses heat and light to clear skin quickly and naturally. Thermage(®) is a non-invasive radiofrequency procedure that improves the appearance of wrinkles, which can result in smoother, more contoured skin. Liposonix(®) is a non-surgical single-treatment procedure that uses advanced high-intensity focused ultrasound technology to destroy targeted fat beneath the skin. VASERshape((TM)) is a complementary non-invasive treatment that combines low frequency, non-focused ultrasound and lymphatic massage to temporarily reduce the appearance of cellulite and improve blood circulation with minimal pain or no downtime. The VASERlipo((TM)) system uses ultrasound technology to selectively remove unwanted body fat. It includes VentX(®) technology that powers an aspiration system for quiet, efficient removal of fatty tissue and precision vented cannulas to maximize aspiration efficiency and speed. VASERsmooth((TM)) is a unique body sculpting add-on tool for use with the VASERlipo system. PowerX(®) is a power-assisted liposuction system that uses a unique rotational motion which can be used with the VASERlipo system or to enhance traditional liposuction systems. The TouchView(®) system fits between the fingers and provides diagnostic imaging of subcutaneous structures during procedures. Both the VASERlipo system and traditional liposuction systems can utilize the Origins((TM)) products, a complete line of custom liposuction infiltration, re-injection and aspiration cannulas and accessories. More than two and a half million procedures have been performed with Solta Medical’s portfolio of products around the world.
SOURCE Solta Medical, Inc.