Tentech obtains medical device certification for its 2-line HIFU equipment ‘10THERA’ in Vietnam

Tentech obtains medical device certification for its 2-line HIFU equipment ‘10THERA’ in Vietnam

Medical device company Tentech (CEO Han Dong Ok) announced on the 5th that it had obtained medical device certification for its 2-line HIFU equipment, '10THERA', from the Vietnamese Ministry of Health on the 3rd.

10THERA lifting is a type of ‘High Intensity Focused UltrasoundㆍHIFU’ lifting. It works by delivering ultrasonic heat energy of 60 to 80 degrees to the target layer.

Currently, 10THERA has obtained overseas certifications in Europe (CE), Taiwan (TFDA), Thailand (TFDA), Saudi Arabia (SFDA), and UAE (MoH), and continuous certification acquisition is in progress. In addition, '10PL', an IPL medical device, has obtained certification in major countries such as the United States (FDA) and Europe (CE), and 'One Thera' has also received medical device certification from Thailand (TFDA).

Tentech is attracting attention as it is proving its global competitiveness by receiving medical device certification overseas one after another. According to the company, '10THERMA', a high-frequency medical device launched in October 2022, received 510(k) approval from the U.S. Food and Drug Administration (FDA) last year. Explains that 10THERMA has been recognized for its excellent technology based on the safety and effectiveness of its products in the United States, the world's largest medical device market.

In addition, 10THERMA has also received certification from regulatory agencies in various countries, including Taiwan (TFDA), Thailand (TFDA), and Indonesia (MoH). Tentech added that it is currently working to obtain overseas certification for 10THERMA and is strengthening its global presence through this.

Han Dong Ok, CEO of Tentech, said, "Our company is currently aggressively carrying out sales and marketing in the domestic market. As a result, we have achieved results, such as achieving cumulative sales of 500 units within one year of the launch of 10THERMA in October last year."

CEO Han continued, “As high-frequency lifting currently accounts for more than 35% of the global non-invasive lifting market, the overseas market is quite large and attractive,” adding, “Tentech will actively pioneer new overseas markets and quickly secure market share.”