Cynosure Lutronic has scored FDA clearance for its monopolar radiofrequency device XERF, with an official U.S. rollout slated for Sept. 12–14 at the company’s Cynosure Lutronic Academy meeting in Miami.

The nod marks the first major product debut since Cynosure and Lutronic merged in April 2024. XERF first launched in Canada in July, and the company said it will leverage its U.S. base to drive marketing and sales as it integrates operations.

Radiofrequency devices deliver heat energy beneath the skin to stimulate collagen and tighten tissue. Unlike conventional RF systems that rely on a single 6.78 MHz frequency, Cynosure Lutronic said XERF adds an extra 2 MHz through a dual-monopolar design, allowing physicians to adjust treatment depth across three levels. 

According to the company, its patented “Spider Pattern” applicator delivers energy over an area as large as 20 x 30 mm per shot, while a built-in cooling system makes procedures possible without anesthesia.

“This milestone will accelerate Cynosure Lutronic’s growth in North America,” CEO Nadav Tomer said in a statement, adding that the company sees XERF as a way to expand RF therapy options for patients and clinicians in the U.S.

XERF is already cleared in Korea, Japan, Hong Kong, Singapore, Vietnam, the Philippines and Canada. Cynosure Lutronic said it expects additional launches in Brazil and Thailand before the end of 2025.