하이로닉 인터내셔널 웹사이트로 이동합니다.
인터내셔널 웹사이트에는 수출용 제품으로 대한민국에서 허가하지 않은 장비 및 서비스 내용을 포함하고 있습니다. 해당 내용은 대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC INTL. website.
The Intrrnation Web Site contains equipment and services that are not authorized by the Republic of Korea These contents are not subject to review and regulation of medical devices in Korea.
하이로닉 US 웹사이트로 이동합니다.
US 웹사이트의 내용은 "FDA"로 부터 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC US website.
The contents of the US web page are about product information of items approved for "FDA". They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.
하이로닉 EU 웹사이트로 이동합니다.
EU 웹사이트의 내용은 "CE MDD 또는 CE MDR"로 부터 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC EU website.
The contents of the EU(European) web page are about product information of items approved for "CEMDD or CEMDR" in EU countries. They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.
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
