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 on May 15 that it has signed an exclusive supply agreement with EMAGE Medical, a U.S.-based medical device distribution company, for its “next-generation RF combination platform” in the United States.
The agreement will be carried out under an OEM model and will remain valid for two years from May 2026. The contract is also structured to allow an extension through mutual agreement between the two companies.
EMAGE Medical is a medical device distribution company headquartered in Charlotte, North Carolina, and has established specialized medical aesthetic sales channels in the United States. During the contract period, EMAGE Medical plans to supply HIRONIC’s platform device under a locally customized brand, based on its exclusive sales and distribution rights across the U.S. market.
The agreement includes a minimum annual purchase quantity clause. According to the company, this provision is intended to ensure active sales activities by the partner company. At the same time, the agreement includes conditions allowing the minimum purchase obligation to be adjusted in consideration of regulatory changes, including the FDA approval timeline, thereby balancing risk management for both parties.
Based on technical and regulatory cooperation with EMAGE Medical, HIRONIC will support the local brand launch in the United States. The company also plans to build clinical case data and establish a network of key opinion leaders, or KOLs.
The “next-generation RF combination platform” is characterized by the integration of RF, or radiofrequency, and Cold Plasma technologies into a single device. With five types of handpieces, including RF microneedling, Cold Plasma, and Circle monopolar RF, the platform supports a wide range of clinical applications, including skin lifting, tightening, scar and wrinkle improvement, and women’s health.
In particular, the company explained that the sequential combination protocol using RF microneedling and Cold Plasma is designed to enhance collagen activation while minimizing post-procedure inflammation.
A HIRONIC official stated, “This exclusive supply agreement in the United States, the world’s largest medical aesthetic market, demonstrates that our technology has been recognized in the global market.” The official added, “We will continue to strengthen our competitiveness in the medical aesthetic market by enhancing our technological capabilities and expanding strategic partnerships.”
Reporter: Seong-hye Kim, hankyung.com
[shkimmy@hankyung.com]
Translation of the original article
Original article link: https://www.hankyung.com/article/202605158616O
