HIRONIC

HIRONIC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SYNERJET PRO™, and has completed all related device and facility registrations. The clearances cover SYNERJET PRO™'s core electrosurgical and microcurrent stimulator functions, while its microjet technology has been formally registered. The milestone marks HIRONIC's expansion into the United States, the world's largest aesthetic medical device market.

A NEEDLE-FREE APPROACH TO SKIN TREATMENT

Already cleared by Korea's Ministry of Food and Drug Safety (MFDS), SYNERJET PRO™ combines HIRONIC's proprietary Cold Plasma and Electroporation technologies with a high-precision microjetting system. Where traditional needle-based treatments can involve pain, downtime, and results that vary with practitioner skill, SYNERJET PRO™ delivers cold plasma energy and microcurrent stimulation directly to the skin's surface through a dedicated plasma handpiece and a distance-controlled electroporation tip. The microjet then delivers active solutions through the skin with greater consistency and less impact on surrounding tissue.

BUILT FOR THE GROWING SKIN BOOSTER MARKET

As the skin booster category expands rapidly alongside Botox and fillers, SYNERJET PRO™ has gained traction among practitioners and patients seeking effective results with minimal pain and downtime. The device combines three energy modalities in a single treatment, adapts to a wide range of skin conditions, and maintains stable performance over extended use — all contributing to significantly improved absorption of active ingredients. Treatment times are short and require no separate anesthesia, with customized application available across areas such as the face and scalp.

A RIGOROUS CLEARANCE, AND A PLATFORM FOR GLOBAL GROWTH

FDA 510(k) clearance reflects one of the most demanding regulatory reviews in the medical device industry, confirming that SYNERJET PRO™'s electrosurgical and microcurrent stimulator functions meet strict U.S. safety and performance standards. Supported by HIRONIC's own clinical and technical data, the clearance strengthens confidence among medical institutions and distribution partners worldwide.

With the U.S. market — valued at roughly KRW 12 trillion annually — now in reach, HIRONIC will begin full-scale supply of SYNERJET PRO™ through local distribution partners. The company plans to use this clearance as a foundation for accelerating regulatory approvals and distribution expansion across Europe, the Middle East, and Asia.

"FDA clearance for SYNERJET PRO™ reflects the strength of HIRONIC's technology being recognized on the global stage," said CEO Jinwoo Lee. "Starting with the U.S., we will continue delivering differentiated solutions in the global aesthetic device market and driving sustained revenue growth."

Device classifications and approved uses may vary by country. Please refer to local regulatory authorities for country-specific approval details.​