Lameditech Co., Ltd. (CEO Choi Jong-seok), a specialized laser healthcare and beauty device company, announced on the 5th that it has obtained a manufacturing and sales certificate for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of Health, Labour and Welfare of Japan for its excimer phototherapy device brand 'CAREVEAM' for skin disease treatment.
CAREVEAM, an excimer phototherapy device, is a 308nm UVB wavelength-based skin disease treatment medical device used to treat autoimmune disorders such as vitiligo and psoriasis and inflammatory skin diseases. Compared to overseas third-party equipment released in the global market, this product is very easy to use because the handpiece is very light and small in size, and it is evaluated as having much better performance and price than third-party products.
Meanwhile, this licensing was completed after a licensing period of approximately 3 years following the signing of a Carebeam distribution contract for the Japanese market with 'GUNZE MEDICAL LIMITED', LamediTech's Japanese business partner. As PMDA is a pharmaceutical and medical device registration management agency under the Ministry of Health, Labour and Welfare of Japan and has a complicated licensing procedure, it is difficult to obtain certification, so it is expected that this licensing will simultaneously secure both product quality and stability.
Lastly, according to a Ramedic official, Ramedic's Japanese business partner, 'GENZE MEDICAL LIMITED', has secured a distribution network of over 1,000 hospitals in Japan, and "starting with the completion of approval in Japan, sales in Japan will begin in earnest, and this will play a major role in the external growth of Ramedic."
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