DUOTITE Registered as a Medical Device in Thailand
VIO Medical completed Thai FDA registration for its DUOTITE high-intensity focused ultrasound lifting device on October 1.
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VIO Medical said DUOTITE has been registered with the Thai Food and Drug Administration under Thailand's Ministry of Public Health, marking the device's entry into the Thai market.
How the device is designed
VIO Medical designed DUOTITE to use high-intensity focused ultrasound, or HIFU, to deliver thermal energy to the superficial musculoaponeurotic system, known as the SMAS layer, and to the dermis.
Thai regulatory classification
The Thai FDA registration certificate classifies DUOTITE as a Class 3, non-IVD medical device. VIO Medical had formally launched the device in South Korea in March 2026.
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