HIRONC

HIRONIC announced that its non-invasive skin improvement medical device, SYNERJET PRO®, has officially obtained domestic medical device approval after successfully passing the Medical Device Technical Document Review (SR) by the Ministry of Food and Drug Safety (MFDS) and completing the certification application process through the National Institute of Medical Device Safety Information.

This approval officially recognizes that HIRONIC’s independently developed needle-free microjet technology complies with domestic medical device standards and specifications. It is expected to serve as an opportunity to strengthen both HIRONIC’s competitiveness in the domestic market and its credibility in the global market.

SYNERJET PRO® is a non-invasive drug and cosmetic solution delivery medical device based on Needle-free Microjetting technology independently developed by HIRONIC. It delivers active ingredients evenly into the skin layers using pressure alone, without needles, making it applicable to a wide range of dermatology and plastic surgery procedures, including treatments for patients with needle phobia. By expanding its lineup from the existing SYNERJET to the upgraded SYNERJET PRO®, HIRONIC is demonstrating strong potential in multiple application areas, including skin elasticity improvement, hydration, and drug delivery.

During this review, HIRONIC received final conformity judgment from the Korea Testing & Research Institute (KTR) for SYNERJET PRO® as a combination medical device consisting of a jet injector and a low-frequency stimulator.

Obtaining domestic approval for SYNERJET PRO® carries significant business value for HIRONIC. As SYNERJET, which had previously been supplied only for export, can now be officially used by domestic dermatology clinics, plastic surgery clinics, and medical aesthetic institutions, HIRONIC has secured a foundation for domestic sales growth. In addition, based on MFDS approval, which is highly trusted internationally, the company is expected to further strengthen its negotiating power with overseas buyers and partners.

Furthermore, by securing domestic medical device status, HIRONIC will be able to formalize clinical cooperation with Korean medical specialists and build an official KOL (Key Opinion Leader) network. This approval is also expected to serve as an important precedent for future approval applications for next-generation needle-free injector lineups, including SYNERJET PRO®.

HIRONIC plans to immediately proceed with the certification application to the National Institute of Medical Device Safety Information (NIDS), with the goal of receiving the final approval certificate within April 2026. After receiving the certificate, the company plans to accelerate individual certifications for major global markets, including the United States, and further establish its positioning as a premium needle-free injector brand.

Reporter: Wonji Lee

news21g@etnews.com
Original Article: https://www.etnews.com/20260422000210

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