US-based medical aesthetics provider Solta Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Fraxel DUAL 1550/1927 laser system, which can be used to treat pigmented lesions including solar lentigos (sun spots) and ephelides (freckles) and lentigos (age spots).
The Fraxel DUAL system is an advanced skin resurfacing technology that regenerates skin and helps maintain skin’s youthful glow despite a person’s age or skin color, with minimal discomfort and downtime.
The Fraxel DUAL system is a fractional laser system that safely penetrates the skin down to the dermis without disturbing the skin’s protective surface, thus maximizing safety and recovery time.
Besides the treatment of pigmented lesions, the Fraxel DUAL system can be used in dermatological procedures that require the coagulation of soft tissue, as well as for skin resurfacing procedures.
It can also be used for such as actinic keratosis (AKs), melasma, treatment of periorbital wrinkles, acne scars and surgical scars.
Solta Medical president and CEO Stephen Fanning said, "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."