Lynk Solutec announced the successful completion of FDA Class I medical device registration for its LYNKS Frontalis Suspension Set, a suture product used in ptosis (drooping eyelid) correction surgery, on January 23, 2026.

FDA Class I designation is granted to medical devices with an established safety profile and represents the foundational regulatory requirement for lawful sale and distribution in the United States market. With this registration, Lynk Solutec has met the official prerequisites for commercial entry into the U.S. medical device market.

Lynk Solutec regards this registration as a significant milestone in its U.S. market entry strategy and plans to accelerate discussions with prospective distribution partners in the region.