Expands Approval Network to Mexico Following Europe, Taiwan, Vietnam, Indonesia, Thailand, and Saudi Arabia.
“With this approval, we are one step closer to capturing the North American and Latin American markets.”

Tentech (CEO Han Dong-Ok) announced that its medical aesthetic device, 10THERA, has received approval from COFEPRIS, the Federal Commission for Protection Against Health Risks under the Mexican Ministry of Health.

According to the company on the 23rd, this approval marks the official entry of 10THERA into the Mexican market, and it is seen as a step forward in advancing their efforts to target the Latin American and North American markets.

10THERA is an advanced device utilizing 2-line High-Intensity Focused Ultrasound (HIFU) technology. Compared to existing products, it enables faster and more effective treatments. The device delivers high-temperature energy deep into the skin's SMAS (Superficial Muscular Aponeurotic System) layer, promoting collagen production and regenerating collagen and elastin fibers without damaging the skin. This process results in enhanced skin elasticity, the formation of a V-line facial contour, and wrinkle reduction, achieving significant aesthetic improvements.

Unlike conventional HIFU devices, 10THERA employs an applicator featuring a 2-line approach, significantly reducing treatment time while delivering consistent energy per shot, thereby enhancing overall treatment efficiency.

A company representative stated, “With this COFEPRIS approval, 10THERA has been recognized for its quality and safety in numerous countries, including Europe (CE), Taiwan (TFDA), Vietnam (MoH), Indonesia (MoH), Thailand (TFDA), Saudi Arabia (SFDA), and UAE (MoHAP). Based on this recognition, 10THERA is solidifying its position as a standout device in the global aesthetic and dermatological markets.”

Mexico is the second-largest medical device consumer market in Latin America after Brazil and serves as a manufacturing and distribution hub connected to North America. As of 2023, Mexico ranks as the 6th largest exporter and 10th largest importer of medical devices globally. Its medical device manufacturing sector is a vital industry, bolstered by a population of 130 million people.

CEO Han Dong-Ok commented, “The COFEPRIS certification is a testament to 10THERA’s outstanding technology and safety. It serves as a springboard for accelerating our expansion into the North American and Latin American markets.”