Solta Medical secures FDA 510(k) clearance for skin smoothing Thermage FLX System

Solta Medical has received 510(k) clearance from its Thermage FLX System from the US Food and Drug Administration (FDA).

Thermage FLX is the latest generation of Thermage technology to non-invasively minimise the appearance of lines and wrinkles.

This system makes use of a patented radio frequency technology, which creates a uniform heating effect in the deep collagen-rich layers of the skin. This process tightens the existing collagen and stimulates in production of new collagen.

The Thermage FLX comes with new optimised energy delivery algorithm AccuREP, which automatically measures and accordingly tunes the amount of energy required to be delivered to the treatment area. It also features a vibrating hand-piece that bolsters patient comfort and reduces treatment time by 25%.

Valeant chairman and CEO Joseph C. Papa said: "As the demand for skin tightening procedures continues to rise, we have continued to evolve and enhance our Thermage technology to meet the needs of skincare physicians and their patients who are looking for ways to achieve smoother skin with natural looking results.

"With the approval of the Thermage FLX through our Solta business, a pioneer and leader in the aesthetic industry, treatments are now faster and more patient-friendly."

Thermage FLX system is expected to be commercially available before the end of this year.