TENTECH, a medical device company specializing in skin aesthetics, announced on the 26th that its radiofrequency (RF) lifting medical device, ‘10THERMA,’ has received official certification from the medical device licensing authority under the Ministry of Health of the Russian Federation.

With this certification, TENTECH is now authorized to officially distribute and supply 10THERMA to medical institutions in Russia, expanding its business footprint into the Russian market following its presence in Europe, the Middle East, Asia, and Latin America.

10THERMA is a lifting medical device used to induce collagen production and improve skin elasticity and wrinkles by delivering 6.78MHz monopolar radiofrequency (RF) energy with a maximum output of 400W. The 10THERMA tip, measuring 5.0cm², provides a 25% larger treatment area compared to conventional tips. It features a cooling pulse that sprays seven times during each shot, reducing pain and the risk of burns.

Amidst the growing global demand for non-invasive RF lifting treatments, Russia is considered a major consumer market with a population of approximately 140 million and a steadily growing sector for skin aesthetics medical devices. In particular, the market potential for RF lifting medical devices is evaluated to be very high.

Based on this certification, TENTECH plans to work with local distribution partners to respond to the demand for 'K-Beauty and Medical' in Russia.

Prior to this Russian certification, TENTECH completed certifications for 10THERMA and 10THERA in major countries, including South Korea (MFDS), Europe (CE MDR), Australia (TGA), the United States (FDA), Brazil (ANVISA), India (CDSCO), and Mexico (COFEPRIS). It also holds approvals in major Asian and Middle Eastern countries, such as Taiwan, Vietnam, Thailand, Indonesia, the Philippines, Saudi Arabia, and the UAE.

TENTECH continues to accelerate its global market expansion based on its extensive portfolio of international certifications.

Dong-ok Han, CEO of TENTECH, said, "Obtaining regulatory approval in Russia once again confirms the technological capability and safety of 10THERMA." He added, "Taking this entry into the Russian market as an opportunity, we will also consider expanding into neighboring Eastern European countries, while continuing to target Asian and Latin American markets to elevate the status of K-Medical worldwide."