Medical Device or Cosmetic Device in Korea? Hand Held Wrinkle Reduction LED Light

S

Slaterson22

#1
I have a hand-held LED light for the reduction and elimination of fine lines and wrinkles. It creates collagen and plumps the skin up and pushes out the wrinkles. Under the FDA, I have a medical device. Does anyone know if this is a medical device in Korea, or would it be more for cosmetic purposes? I do not think that wrinkles are a medical condition in Korea. But, it alters structures or functions of the bodies. It does build collagen and stimulate cells in the dermis layer. Any help would be deeply appreciated. Thanks!
 
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M

MIREGMGR

#2
This document http :// www. ita. doc. gov/td/health/korearegs.htm bears on your question from several directions. - DEAD - 404 - LINK UNLINKED

Most importantly, since you (probably) would have to register your product in Korea through your Korean distributor and they would have regulatory responsibility for it in that market, they should be asked to definitely obtain an answer to the question.
 
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