‘Healux’ Receives FDA 510(K) Clearance for ‘i-THREAD’ in the U.S.

Date: May 13th, 2024

Article approved on April 23rd, 16:01, 2024

Link: 힐룩스, 아이쓰레드 미국 FDA 510(K) 허가 획득 - 아시아투데이 (asiatoday.co.kr)

ASIA TODAY – Health & Medical section

‘Healux’ Receives FDA 510(K) Clearance for ‘i-THREAD’ in the U.S.

/ Healux Co.,Ltd.

On April 23rd, 2024, ‘Healux Co.,Ltd.’ announced that ‘i-THREAD’ has received U.S. Food and Drug Administration (FDA) 510K clearance (registration number K240389).

According to the company, ‘i-THREAD’ is a PDO-based lifting thread for facial tissue fixation, which is an absorbable material used to pull and fix skin tissue to improve facial wrinkles.

‘i-THREAD’ is a dedicated lifting thread certified by MFDS in Korea, CE in Europe, and ANVISA in Brazil, and is exported to more than 40 countries around the world. With this FDA clearance, ‘i-THREAD’ can be used for lifting procedures in general and plastic surgery in the United States.

"The U.S. FDA 510K clearance of ‘i-THREAD’ products is a recognition of the safety and excellence of ‘i-THREAD’ in the U.S." said Do Yeun Kim, CEO of ‘Healux’, “and will expand our exports, which are currently concentrated in Latin America and Southeast Asia, to markets around the world."

Ø  Written by Si Young Kim – Medical journalist

         (Economic Policy Division, kimsy@asiatoday.co.kr)