The CoolSculpting procedure is a non-surgical and clinically proven procedure, which selectively reduces fat bulges in problem areas using a patented cooling technology.

In line with this approval, the company now is set to introduce its brand new applicator, CoolSmooth PRO in the second quarter of this year, which is a surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges such as the outer thigh area.

ZELTIQ Aesthetics president and CEO Mark Foley said: "This FDA clearance will enable healthcare professionals to perform the CoolSmooth procedure in nearly half the time with the same outcomes, which will significantly enhance the procedural efficiency and profitability for the practice while also improving the patient experience.

"Through an ongoing investment in R&D and technological innovation, we are pleased to continue to provide our CoolSculpting partners with differentiated solutions that enhance their treatment options."

The approval was based on clinical study data, which demonstrated that optimized temperatures enable shorter treatment times with equivalent benefits, safety, efficacy and customer satisfaction compared against current CoolSculpting procedures, noted ZELTIQ.

Initially, the new treatment parameters will be provided with the CoolSmooth PRO applicator, which allows in controlling treatments at colder temperatures.

The CoolSmooth PRO applicator features an enhanced strapping system, which offers increased conformity at the treatment site, as well as improves ease of use and patient comfort.