We Are Proud to Announce FDA Cleared for the MIRARI Cold Plasma System!

We are excited to announce a significant milestone: the MIRARI Cold Plasma System has officially been FDA cleared by the U.S. Food and Drug Administration in November 2024 (Certificate No. 3959-1-2025-1).

This FDA clearance confirms that the MIRARI Cold Plasma System meets strict standards for safety and efficacy as a medical device in the United States. It marks a major step forward in our mission to bring non-invasive, science-backed solutions to healthcare professionals worldwide.

Setting a New Standard in Cold Plasma Therapy

Designed and manufactured by General Vibronics, the MIRARI Cold Plasma System uses reactive oxygen and nitrogen species (RONS) to deliver powerful sterilization, anti-inflammatory effects, and tissue regeneration stimulation—all while avoiding thermal damage to healthy tissue. It is an innovative, non-invasive therapeutic platform that redefines what’s possible in modern medicine.

With over 20 granted patents and multiple international awards, the MIRARI system is already making an impact in countries like Vietnam and Thailand, where hundreds of medical and aesthetic professionals use it in daily practice.

Expanding Global Reach with Confidence

FDA clearance opens the door for broader use of the MIRARI Cold Plasma System system across the United States, enabling new clinical partnerships and applications in various fields of medicine and aesthetics. We are proud to contribute to a global movement toward safer, more effective, and more accessible care.

Gratitude and Next Steps

We would like to thank our dedicated team, partners, and early adopters who have supported our journey. Your trust and collaboration were key to achieving this milestone.

Stay tuned as we continue to share updates, case studies, and opportunities to experience the MIRARI Cold Plasma System in action.