Lynk Solutec has received a Rare Medical Device designation from the Ministry of Food and Drug Safety (MFDS) for its LYNKS Frontalis Suspension Set, a suture indicated for ptosis correction surgery. Details are as follows.
- Product: LYNKS Frontalis Suspension Set (Non-absorbable Suture)
- Designating Authority: Ministry of Food and Drug Safety (MFDS), Republic of Korea
- Designation Date: January 2025
- Indication: Surgical correction of ptosis (drooping eyelid) in pediatric and adult patients
- Designation Background
- Product discontinuation following ownership change and business conversion of the sole global manufacturer
- Designated as an urgently needed medical device due to absence of domestic supply alternatives
(END)
