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【South Korea】TENTEK Obtains Russian Regulatory Approval for RF Lifting Device '10THERMA'

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Editor's note

This development signals TENTEK's strategic expansion into Russia, a growing market for non-invasive aesthetic devices. The certification, sourced from the Russian Ministry of Health, mitigates supply-chain risk by enabling legal distribution. Buyer relevance lies in the device's enhanced safety features and larger treatment area, though regulatory questions may arise regarding compliance with local standards.

TENTEK, a South Korean company specializing in aesthetic medical devices, announced on May 26 that its radiofrequency (RF) lifting device '10THERMA' has received official certification from the medical device regulatory authority under the Russian Ministry of Health. With this certification, TENTEK can now legally distribute and supply 10THERMA to medical institutions in Russia, expanding its market presence beyond Europe, the Middle East, Asia, and Latin America. 10THERMA is a non-invasive RF lifting device that uses a single 6.78 MHz frequency with a maximum output of 400W to stimulate collagen production, improving skin elasticity and reducing wrinkles. Its 5.0 cm² treatment tip offers a 25% larger treatment area compared to conventional tips, and it features seven cooling pulses per shot to minimize pain and burn risk.

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Russia, with a population of approximately 140 million, is seen as a growing market for aesthetic medical devices, particularly for non-invasive RF lifting procedures. TENTEK plans to partner with local distributors to meet the demand for K-beauty and medical aesthetics in the region. Prior to this Russian approval, TENTEK had secured certifications for 10THERMA and its related device '10THERA' in South Korea (MFDS), Europe (CE MDR), Australia (TGA), the United States (FDA), Brazil (ANVISA), India (CDSCO), and Mexico (COFEPRIS). The company also holds certifications in Taiwan, Vietnam, Thailand, Indonesia, the Philippines, Saudi Arabia, and the UAE.

난청 방치하면 인지 저하와 치매 위험에도 영향…“인공와우가 효과적 대안”

"This Russian certification reaffirms the technological excellence and safety of 10THERMA," said Han Dong-ok, CEO of TENTEK. "We will use this entry into the Russian market as a springboard to explore neighboring Eastern European countries, while continuing to strengthen our presence in Asia and Latin America, elevating the status of K-medical aesthetics."

Source: Read the original report | Published: May 26, 2026