FDA approves Fraxel Dual Laser System (Solta Medical) for Skin Pigmentation treatment
Solta Medical has received 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 system works by beaming laser light onto the skin that penetrates down to the dermis and which then stimulates new collagen creation.
In addition, the Fraxel Dual system is FDA 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, Melasma, treatment of periorbital wrinkles, Acne scars and surgical scars. The laser system received CE mark approval in the EU in 2009.
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