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  • TitleHIRONIC'S PLASONIC DEVICE ACHIEVES FDA APPROVAL: AN INNOVATIVE ME…
  • Hit555
  • 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.

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