[Edaily Reporter Shin Ha-yeon ] Hironic Co.,Ltd(149980)announced on the 10th that its next-generation aesthetic medical device, the “SYNERJET PRO,” has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its transcutaneous electrical stimulation function for aesthetic purposes.

This approval pertains to the transcutaneous electrical stimulation (TES) function for aesthetic purposes; the approval number is K260387, and the decision date was the 31st of last month.

Previously, in April, Hironic Co.,Ltd obtained FDA 510(k) clearance for the Synerget Pro’s electrosurgical function (K260397). This function is intended for the removal or destruction of skin lesions and tissue coagulation. Both applications were submitted together in February, underwent separate reviews, and received clearance sequentially.

As a result, the Synerget Pro has secured the necessary sales requirements in the U.S. market for two functions: plasma-based electrosurgery and transcutaneous electrical stimulation for aesthetic purposes. Hironic Co.,Ltd plans to continue the regulatory approval process for the remaining functions while preparing to enter the U.S. market in collaboration with local distribution partners.

Recently, Hironic Co.,Ltd has also been accelerating its efforts to penetrate domestic and international aesthetic medical device markets. In South Korea, the company has begun full-scale distribution of the Synerget Pro to major hospitals and clinics. On the 2nd, it began distributing the initial North American shipment of the “Doublo × Venus Signature Edition” in partnership with global medical aesthetics company Venus Concept. The company plans to leverage this additional approval for the Synerget Pro to accelerate its business expansion in North America.

The Synerget Pro is a non-invasive skin energy medical device approved by the Korean Ministry of Food and Drug Safety (MFDS), combining Cold Plasma, Electroporation, and Microjet technologies developed by Hironic Co.,Ltd. It is characterized by its ability to deliver energy to the skin’s surface without needles, using a dedicated plasma handpiece and a distance-controlled electroporation tip.

Under domestic approval standards, it was authorized as a device that delivers medicinal solutions through the skin using microjets traveling at 580 meters per second. It can be applied to the face and scalp using two types of dedicated handpieces: the plasma handpiece and the electroporation tip.

Building on this FDA approval, Hironic Co.,Ltd plans to pursue regulatory approvals and expand its distribution network in Europe, the Middle East, and Asia.

Lee Jin-woo, CEO of Hironic Co.,Ltd, stated, “The FDA approval of Synerjet Pro is a testament to Hironic Co.,Ltd’s technological capabilities being recognized on the global stage,” adding, “Starting with the U.S., we will continue to provide differentiated solutions in the global aesthetic medical device market.”