Hironic, a Korean medical device company, said Thursday that it has received Ministry of Food and Drug Safety (MFDS) certification for Q-Fit, a medical device.
Q-Fit is a Nd:YAG laser equipment that treats pigmented lesions by using laser beams of two wavelengths -- 532 and 1064 nanometers -- to deliver high heat during a short time span. The device medically used a property where laser evaporates moisture after coming in contact with living tissues.
The device has also included various functions to improve its convenience. Such functions include four different handpieces for different depth and size of the lesions and a Q-Fit toning mode for laser irradiation. It also has two cooling chambers and a noise fan, which reduces noise.
The company received export approval from the ministry in February.
“Q-Fit has been attracting attention through various domestic forums and exhibitions since the fourth quarter of this year,” a company official said. “With the ministry’s certification, our company plans to launch the product in Korea officially.”
The company will also actively pursue overseas and domestic marketing with its European CE certification for Doublo Gold, a high-intensity focused ultrasound device, and the Korean government’s accreditation for Q-Fit, he added.
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