After the closing bell on Wednesday, Solta Medical Inc. (SLTM) announced that the U.S. Food and Drug Administration (FDA) approved its device to clear pigmentation and other superficial skin conditions.
The device, called the Fraxel re:store Dual Laser System, can be used both on the face and large body areas to clear pigmentation through a single treatment.
Solta has already received approval for the device with 1550 nanometer (nm) wavelength for skin resurfacing and treatment of pigmented lesions and certain other dermatological conditions.
The present FDA 510(k) clearance is for the Fraxel 1927 nm laser for dermatological procedures requiring the coagulation of soft tissue. Prior to its approval, laser skin resurfacing procedures were largely limited to the face. The approval of the new 1927 nm wavelength increases the areas of the body that physicians can treat, which are further indications of Solta’s continued efforts to produce the safest and most effective aesthetic energy devices in the industry.
The news of the U.S. agency approving the newer version of the laser device had a positive impact on the company’s shares, which rose by 31 % to $2.89 in aftermarket trading on the Nasdaq. The company closed Tuesday at $2.19.
Solta Medical, headquartered in Hayward, California provides aesthetic and therapeutic solutions for patients. Its offerings address aging skin under two premier brands: Thermage and Fraxel. Thermage is a non-invasive radiofrequency procedure aimed at tightening and contouring the skin. Fraxel delivers invasive clinical solutions to resurface aging skin in addition to skin damaged by the sun. The procedure can be performed on any part of the body to treat wrinkles. Solta competes with players like Allergan Inc. (AGN) and Candela Corp. (CLZR) in the Medical Appliances & Equipment industry.
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