[Hinews] SEOUL, South Korea — Cynosure Lutronic, a global leader in energy-based medical devices, announced on August 21 that its monopolar radiofrequency (RF) device, XERF, has received clearance from the U.S. Food and Drug Administration (FDA). This milestone paves the way for the company to accelerate its expansion into the lucrative North American market.

The FDA approval follows a successful launch in Canada in July, positioning XERF as a cornerstone of Cynosure Lutronic’s strategy to capture the U.S. medical device market. The device, the first product released since the merger of Cynosure and Lutronic, is set to debut officially at the Cynosure Lutronic Academy, a global conference scheduled for September in Miami.

XERF features a dual-frequency system, combining 6.78 MHz with an additional 2 MHz, and offers three depth settings for precise treatment customization. The device incorporates a patent-pending “Spider Pattern” technology, which expands the treatment area in a single session. A built-in cooling system eliminates the need for separate anesthesia, enhancing patient comfort during procedures.

“Cynosure Lutronic has reached a significant milestone with this FDA clearance, marking a pivotal step in our North American expansion,” said Nadav Tomer, CEO of Cynosure Lutronic. “We are thrilled to offer medical professionals and patients a new standard in radiofrequency treatments.”

XERF device and logo image (provided by Cynosure Lutronic)
XERF device and logo image (provided by Cynosure Lutronic)

The company emphasized that the FDA approval validates XERF’s safety and efficacy. “This clearance underscores the device’s reliability and performance,” a Cynosure Lutronic spokesperson said. “We are committed to further expanding regulatory approvals and strengthening our global customer network.”

XERF is already available in markets including South Korea, Canada, Japan, Hong Kong, and Singapore. The company plans to extend its reach to the U.S., Brazil, and Thailand by the end of the year, capitalizing on growing demand for advanced aesthetic and medical RF technologies.

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