Hironic Launches Two-Track U.S. Strategy as SYNERJET PRO Receives Second FDA Clearance

[Financial News] Hironic, a company specializing in aesthetic medical devices, is accelerating its push into the U.S. market. The company has begun distributing existing products in North America with a global medical-aesthetics company while expanding the scope of U.S. Food and Drug Administration (FDA) clearance for its next-generation product, SYNERJET PRO.
According to Hironic on the 10th, SYNERJET PRO received FDA 510(k) clearance for its transcutaneous electrical stimulation function for aesthetic use. This marks its second clearance, following approval for its electrosurgical function in April. Hironic has consequently secured the requirements to sell the device in the United States for two key functions: plasma-based electrosurgery and transcutaneous electrical stimulation for aesthetic use.
SYNERJET PRO is a noninvasive skin-energy medical device independently developed by Hironic. It combines low-temperature plasma, electroporation and microjet technologies. Its needle-free method delivers energy to the skin’s surface without needles, reducing pain and recovery downtime.
The device is specifically targeting the growing skin-booster market, which has expanded beyond Botox and fillers. In South Korea, it has been approved as a device that delivers liquid medication through the skin using a microjet traveling at 580 meters per second.
The clearance comes as Hironic expands its North American business. On the 2nd, the company began distributing initial shipments of the “Doublo × Venus Signature Edition” in North America with global medical-aesthetics device company Venus Concept. This represents a two-track strategy: securing local distribution channels for existing products while pursuing FDA clearance for next-generation products.
An industry official said, “For aesthetic medical devices, securing local distribution channels, not just regulatory clearance, is the key to converting sales into actual revenue. The simultaneous acquisition of North American sales channels and regulatory clearance for next-generation products will be crucial to establishing a foothold in the market.”
Meanwhile, Hironic plans to continue seeking U.S. regulatory clearance for SYNERJET PRO’s remaining functions while expanding its distribution network into Europe, the Middle East and Asia.
Lee Jin-woo, CEO of Hironic, emphasized, “Starting with the United States, we will continue providing differentiated solutions in the global aesthetic medical device market.”
[email protected] Kim Kyung-ah Reporter