April 15, 2025, Tentech HIFU lifting device “10THERA” has officially obtained certification from the Brazilian Health Regulatory Agency (ANVISA) on April 14.

10THERA is an advanced device utilizing 2-line High-Intensity-Focused Ultrasound (HIFU) technology, significantly reducing procedure time while delivering uniform energy per shot, across a consistent depth and wide treatment area.

Its designed for both practitioner convenience and patient satisfaction, enabling fast and precise procedures.

A company representative stated, ”Unlike conventional single-line HIFU devices, 2-line HIFU technology ensuring both procedural efficiency and safety.” “It is a product specifically designed to meet the global demand for shorter treatment times and superior lifting results.” he added.

Brazil is the largest consumer of medical devices in Latin America and a key market for aesthetic and cosmetic treatments, obtaining ANVISA certification is essential for entering the market

Especially, with an annual aesthetic market is valued at around 30 trillion won, ranking second globally in the number of aesthetic procedures(8.9%), Brazil continues to show strong growth momentum.

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

CEO Han Dong-ok stated:“ The ANVISA certification is a significant achievement that validates the technology and safety of 10THERA on a global level.” he added “We will accelerate our expansion across Latin America, starting with Brazil, and actively pursue growth in the North American and European markets.”

In addition to 10THERA, monopolar RF device 10THERMA also secured key certifications in major markets including the U.S.A (FDA), Taiwan (TFDA), Saudi Arabia (SFDA), and the UAE (MoHAP), further strengthening its foothold in the global market.

10THERA has also obtained certifications in several other countries, including Philippine, Mexico, and Europe, accelerating Tentech’s global expansion in the aesthetic medical device market."