main contents menu area
Press Center
The Newest Updates on Hironic

News

  • TitleHIRONIC'S PLASONIC DEVICE ACHIEVES FDA APPROVAL: AN INNOVATIVE ME…
  • Hit197
  • Date24-11-11 10:37
HIRONIC Co., Ltd. announced that its innovative plasma device, Plasonic, has received FDA approval from the U.S. Food and Drug Administration. This marks HIRONIC’s second FDA approval following the certification of Silkro, further establishing the company's reputation for safe and effective skin aesthetic medical technology.

Plasonic harnesses plasma, known as the fourth state of matter (beyond solid, liquid, and gas), which is a naturally occurring ionized energy often observed in natural phenomena. Renowned for its sterilization and regenerative properties, plasma-based skin treatments have already become mainstream across Europe.

Plasonic combines two mechanisms—plasma and ultrasound—to maximize the absorption of cosmetic or skin booster ingredients. Plasma ions create a membrane potential effect on the skin, creating microchannels between skin cells, allowing ingredients to penetrate deeply and enhance the skin’s absorption, promoting aesthetic improvements. Equipped with the Plapass (plasma) and Sonopass (ultrasound) handpieces, Plasonic delivers precise and effective treatments that remove skin lesions with minimal damage, ensuring safe procedures. In tests conducted by the Korean Dermatology Research Institute, skin treated with Plasonic’s plasma showed 4.66 times greater permeability than untreated skin, validating the role of ultrasound in enhancing the penetration of active ingredients.

A HIRONIC spokesperson stated, “FDA approval for Plasonic will enable HIRONIC to distinguish itself in the global skin booster market, including the United States. With this recognition of our innovative technology and safety, we are committed to providing North American customers with advanced aesthetic medical technology that guarantees both innovation and safety.”

The global skin booster market, valued at $1 billion in 2022, is projected to grow at an annual rate of 10%, reaching an estimated $2.1 billion by 2030. Currently, injectables dominate over 90% of the skin booster market, but the EBD (Energy-Based Device) sector is expanding rapidly. Given the significant growth in the U.S. medspa market, HIRONIC’s FDA approval paves the way for substantial achievements in the U.S. market.

c5203d71051cc6d15df4a2309f8ee727_1731289

  • URL
  • File (0)
하이로닉 로고

하이로닉 영문 웹사이트로 이동합니다.
글로벌 웹사이트에는 수출용 제품으로
대한민국에서 허가하지 않은 장비 및 서비스
내용을 포함하고 있습니다. 해당 내용은
대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.

영문 웹사이트 →

It goes to the HIRONIC English website.
The Global 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.

English Website →
닫기
하이로닉 로고

하이로닉 EU 웹사이트로 이동합니다.
EU(Europe) 웹사이트의 내용은 "CE MDD 또는 CE MDR" 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.

EU 웹사이트 →

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.

EU Website →
닫기
하이로닉 로고

하이로닉 중국어 웹사이트로 이동합니다.
중국어 웹사이트에는 중국내 판매제품으로
대한민국에서 허가하지 않은 장비 및 서비스
내용을 포함하고 있습니다. 해당 내용은
대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.

중국어 웹사이트 →

正在移动到HIRONIC的中文官网。
在中问官网内介绍的产品只在中国销售的产品,
不一定是在韩国得到认可和服务内容。
针对这内容没有受到韩国医疗仪器广告审议限制。

中文官网 →
닫기