[Medical Today = Reporter Choi Min-seok] TENTECH announced on the 19th that its radiofrequency (RF) lifting device, '10THERMA', has received medical device approval from the Mexican Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
This approval marks another milestone in TENTECH's global market expansion, as it allows the company to officially distribute and supply its product to medical institutions within Mexico, a key market in Latin America.
Mexico is a major Latin American market with a population of approximately 120 million. With recent economic growth, the demand for aesthetic and plastic surgery is rapidly increasing. There is a growing preference for non-invasive RF lifting treatments, which has led to a steady rise in demand for energy-based medical devices like '10THERMA'. With this approval, TENTECH plans to collaborate with local distribution partners in Mexico to accelerate product supply and marketing activities.
'10THERMA' is an aesthetic medical device that delivers a single RF energy at 6.78MHz with a maximum output of 400W to stimulate collagen production and improve skin elasticity and wrinkles. Its 5.0cm² Face Tip provides a 25% wider treatment area than the conventional models. The device also features a cooling pulse that sprays seven times in each shot to minimize pain and the risk of burns.
Previously, TENTECH had already demonstrated its technological prowess in the Latin American market by securing medical device certifications for both '10THERMA' and its HIFU lifting device, '10THERA', from the Brazilian Health Regulatory Agency (ANVISA). The new approval in Mexico, following its success in Brazil, further strengthens TENTECH's position in the LATAM market.
TENTECH has now completed certifications for '10THERMA' and '10THERA' in several major countries, including South Korea (MFDS), the European Union (CE), Australia (TGA), the United States (FDA), Brazil (ANVISA), India (CDSCO), and Mexico (COFEPRIS). Certifications have also been completed in Taiwan (TFDA), Vietnam (MoH), Thailand (TFDA), Indonesia (MoH), the Philippines (FDA), the UAE (MoHAP), and Saudi Arabia (SFDA), earning the company worldwide recognition for its technology and safety.
CEO Han Dong-ok stated, "This COFEPRIS certification in Mexico is further proof of TENTECH's global competitiveness. We will continue our aggressive market expansion, focusing on Asia and Latin America, to further elevate the status of K-Medical."
Reporter Choi Min-seok (press@mdtoday.co.kr)