The US Food and Drug Administration (FDA) has granted 510(k) clearance to Solta Medical's 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, 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 colour, 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."
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.