SinoShore Lutronic, a U.
S.-based global player in the medical aesthetics field, announced on October 20 that its monopolar radiofrequency (RF) device, the XERF, has successfully obtained regulatory approvals across significant markets in the Asia-Pacific (APAC) and Middle East regions, marking a strategic expansion of its global business operations.
The company recently secured final approval from the Emirates Disease Agency (EDE) in the United Arab Emirates (UAE), reinforcing its foothold in the Middle East following a similar certification in Saudi Arabia earlier this January.
This progression indicates SinoShore Lutronic’s intent to actively penetrate key medical aesthetic markets in the region.
Furthermore, the XERF has established its presence in the Oceania market since receiving approval from Australia's Therapeutic Goods Administration (TGA) in October of last year.
With recent certifications in Indonesia and Myanmar, the device's market footprint in the Asia-Pacific region continues to grow.
The XERF has been verified as an optimal device for non-invasive skin aesthetic procedures by regulatory authorities in three APAC countries (Australia, Indonesia, Myanmar) as well as the UAE.
The approved indications encompass facial contouring and wrinkle treatment, eyebrow lifting, and improvements in facial and neck laxity.
Notably, the XERF marks the first product launched by SinoShore Lutronic following its merger.
It employs a dual monopolar configuration, incorporating both the traditional 6.78MHz frequency and a new 2MHz frequency, allowing for customizable treatments that adapt to the depth of the procedure area across three distinct levels.
Additionally, the patented 'Spider Pattern' technology featured in the XERF Effector maximizes treatment efficacy by delivering energy over a larger surface area, with treatment sizes reaching up to 20×30mm.
With the recent regulatory approvals now totaling 13 countries—including the United States, Canada, Brazil, Japan, and South Korea—the growing number of markets where the XERF can operate is expected to generate increased demand not just for the equipment but also for its disposable component, the XERF Effector.
This dual opportunity positions SinoShore Lutronic to establish a stable revenue structure that extends beyond mere device sales.
A representative from SinoShore Lutronic commented, 'Based on non-invasive RF technology, the XERF has captured significant interest from healthcare professionals globally since its launch.
With the successful approvals in the APAC and Middle East regions, we are poised to solidify our leadership in the global RF market. '