IEL Science Registers Polinique Scalp Care Device as Medical Device with US FDA

[Asia Economy Reporter Hyunseok Yoo] IL Science, a KOSDAQ-listed smart optical tech company, announced on the 9th that its scalp and hair care specialized brand FOLLINIC's ‘Microcurrent LED Scalp Care Device’ has been registered as a medical device by the U.S. Food and Drug Administration (FDA).

FOLLINIC’s ‘Microcurrent LED Scalp Care Device’ received Class II approval from the FDA, which corresponds to the level of a home-use medical device. This means it is recognized as a medical device that can be sold in the U.S. with confirmed efficacy and safety.

IL Science is currently proceeding with the necessary procedures to obtain certifications required for entry into major global markets, such as the European Conformity (CE) mark and the U.S. safety standard (UL), following the FDA medical device registration.

FOLLINIC’s ‘Microcurrent LED Scalp Care Device’ is a patented home care device for the scalp that applies the dual effects of microcurrent technology and silicone lens LEDs. When used once daily in total care mode for 20 minutes, it helps optimize scalp condition by promoting blood circulation and cellular activity in the scalp. Weighing approximately 400g, it offers excellent comfort and, as a wireless product, allows mobility and daily activities during use.

In a clinical trial commissioned to the Korean Dermatological Science Institute in May, the device demonstrated effectiveness in key hair loss-related areas, including a 61% improvement in scalp microcirculation, 9.96% increase in hair thickness, 22.90% increase in hair tensile strength, and 37.52% reduction in scalp sebum.

Song Seong-geun, CEO of IL Science, stated, “We plan to continuously strengthen the verification of the efficacy and safety of FOLLINIC’s ‘Microcurrent LED Scalp Care Device’ and accelerate our entry into the global market.”