April 10, 2025 – TENTECH, led by CEO Han Dong-ok, announced that its medical device, 10THERMA, has officially obtained certification from the Brazilian Health Regulatory Agency (ANVISA).

The 10THERMA is a lifting medical device that utilizes a maximum output of 400W and 6.78MHz monopolar RF energy to promote collagen production, effectively improving skin elasticity and reducing wrinkles.

A key feature of the device is its 5.0 cm² face tip, which delivers 25% more energy than the previous 4.0 cm² tip, ensuring more effective treatments. Each session is designed to minimize discomfort, featuring seven cooling pulses in each shot that enhance safety during the procedure.

Brazil, with a population of approximately 200 million, is the largest medical device market in Latin America and is recognized as a significant player in global medical device manufacturing and consumption.

As of 2024, Brazil's annual aesthetic market is valued at around 30 trillion won, ranking second globally in the number of aesthetic procedures, with an 8.9% market share, following the United States (22%). Therefore, obtaining ANVISA certification is essential for the distribution of medical devices in Brazil.

With this certification, TENTECH plans to strengthen its foothold in the local market and enhance collaboration with major aesthetic clinics and hospitals in Brazil.

The country has seen a rapid growth in the aesthetic market, with increasing interest in K-beauty and a growing trust in Korean medical devices. TENTECH aims to boost brand awareness in Brazil through marketing strategies tailored to the local market.

A company representative stated, “With the ANVISA certification, we have secured a foothold for entering the Brazilian market, which will enable us to accelerate our expansion throughout Latin America and eventually into the North American market.” The representative also noted that 10THERMA has received recognition for its technology and safety from multiple countries, including the U.S.A (FDA), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), Thailand (TFDA), Saudi Arabia (SFDA), and the UAE (MoHAP). “We will further strengthen our competitiveness in the Latin American market starting with the certification in Brazil,” they added.

CEO Han Dong-ok remarked, “The acquisition of ANVISA certification is a significant achievement that reaffirms the technology and safety of 10THERMA. We will solidify our presence across Latin America, starting with Brazil, and further expand into the North American market.”

In March 2024, TENTECH received FDA certification for 10THERA from the Philippines, confirming its safety and effectiveness. The 10THERA utilizes 2-line High-Intensity Focused Ultrasound (HIFU) technology, enabling faster and more efficient treatments.

Recently, The 10THERA has received multiple certifications, including COFEPRIS in Mexico, CE in Europe, TFDA in Taiwan, SFDA in Saudi Arabia, and MoHAP in the UAE. Both TENTECH’s 10THERMA and 10THERA have consecutively earned certifications from key countries.