10THERMA approved by CDSCO ••• Brazil, EU, etc, expanding global certification.

April 18, 2025 – TENTECH, led by CEO Han Dong-ok, announced that its monopolar RF lifting device, 10THERMA, has officially obtained certification from the India Central Drugs Standard Control Organization (CDSCO).

This milestone allows 10THERMA to enter official distribution and clinical use in India: the world’s 2nd largest population and a rapidly expanding aesthetics market."

Additionally, Tentech had pre-signed a supply agreement worth approximately USD 6 million with local Indian distributor Spectra in the second half of 2024. With the CDSCO certification now secured, Tentech is set to begin full-scale product delivery and on-site marketing activities in India."

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% larger treatment area than the previous 4.0 cm² tip. Each session is designed to minimize discomfort, featuring seven cooling pulses in each shot that enhance safety during the procedure.

Backed by a population of approximately 1.4 billion, India has seen a rapid growth in the aesthetic market, in recent years, demand for aesthetic and cosmetic procedures has surged.
Especially with a notable rise in preference for non-invasive RF lifting treatments, this trend is driving increased interest in RF energy-based medical devices like 10THERMA.
Following its entry into the Brazilian market, Tentech’s expansion into India strengthens its competitive presence across both Latin America and Asia, marking a key step in its global growth strategy.

Prior to the Indian approval, Tentech secured medical device certifications from Brazil’s National Health Surveillance Agency (ANVISA) for both 10THERMA and 10THERA. These approvals validate Tentech’s technological strength in the Latin American market.

10THERA is an advanced device utilizing 2-line HIFU technology, delivers high-speed, precision treatments, together with 10THERMA as a core driver of Tentech’s global growth.

Tentech has been recognized for its quality and safety in numerous countries now, not only in Korea (MFDS), Europe (CE), Australia (TGA), America (FDA), Brazil (ANVISA), India (CDSCO), but also in Taiwan (TFDA), Vietnam (MOH), Thailand (TFDA), Indonesia (MoH), Philippine (FDA), Saudi Arabia (SFDA), and the UAE (MoHAP).

CEO Han Dong-Ok commented, “The CDSCO certification is a testament to 10THERMA’s outstanding technology and safety.” “Tentech stated its commitment to strengthening the global presence of K-Medical through active expansion in Asia and Latin America, including the Indian market.” he added.