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(2021-06-09) SHEnB ‘PlaDuo’ approved by U.S. FDA, Open the way to export to the US

2021-06-16

 SHEnB ‘PlaDuo’ approved by U.S. FDA, Open the way to export to the US

SHEnB started to export PlaDuo to the U.S market on March 8, about 3 months after it acquired FDA approval on December 15, 2020.

PlaDuo is a medical device developed by SHEnB, a Korean medical device manufacturer, and it is the world's first dual plasma device using two types of plasma. 
PlaDuo is designed to implement dual plasma of argon and nitrogen so that it can treat skin lesions and it is known for its anti-bacterial effect.

Pladuo, developed after four years of development, was the first in Korea to be licensed as plasma using gas, 
and it’s also the first case in Korea to export to the United States among devices in the same field. Sunyoung KANG, CEO of SHEnB, 
a manufacturer of PlaDuo, said, “I am happy to export it eventually in spite of many difficulties in proceeding with the FDA approval for PlaDuo. 
We were able to export it to the U.S in such a short time due to the constant inquiries and interest in PlaDuo from the US. 
This achievement was possible thanks to the stabilization of plasma energy, steady clinical data, and the efforts of R&D employees. 
As PlaDuo is being exported to the US for the first time, we have high expectations and concerns. 
We hope that it will be widely known as good treatment among many patients in the US, as well as in Korea.”


Sunyoung KANG, CEO of SHEnB, and Changwon Choi, chief developer of PlaDuo (left), are standing in front of PlaDuo.

In addition, Changwon Choi, chief developer of PlaDuo, said, “As it’s been painstakingly developed for a long time, 
it’s very meaningful that it will be exported to the US with the U.S. FDA approval. 
We will continue to work hard to develop better products and repay our customers with good products.”

PlaDuo has a total of 4 papers (preclinical, acne, melasma, tinea pedis) including SCI and clinical papers. In 2020, 
it was selected as a next-generation world-class product certified by KOTRA.

 

link : http://www.aestheticnews.co.kr/news/articleView.html?idxno=817