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

General Vibronics’ Cold Plasma Technology Achieves FDA Clearance, Paving Way for American Healthcare Integration

The United States medical device landscape witnessed a significant development in November 2024 as the MIRARI Cold Plasma System secured official clearance from the Food and Drug Administration. This regulatory milestone, documented under Certificate No. 3959-1-2025-1, represents a pivotal moment for non-invasive therapeutic technology entering the American healthcare market.

Regulatory Achievement Validates Advanced Plasma Technology

The FDA clearance process confirmed that General Vibronics’ innovative medical platform meets the stringent safety and efficacy requirements mandated for therapeutic devices in the United States. This approval follows extensive clinical evaluation and regulatory review, establishing the system’s credibility within America’s highly regulated medical device sector.

The clearance specifically validates the device’s use of reactive oxygen and nitrogen species (RONS) to achieve therapeutic outcomes without causing thermal tissue damage. Unlike conventional treatment modalities that may involve heat-based mechanisms, this cold plasma approach operates at room temperature while delivering antimicrobial, anti-inflammatory, and regenerative benefits.

International Foundation Supports US Market Entry

Prior to achieving American regulatory approval, the MIRARI Cold Plasma System has already demonstrated clinical value across international markets. Healthcare professionals in Vietnam and Thailand have integrated the technology into routine medical and aesthetic practice, with hundreds of practitioners currently utilizing the system for patient care.

The device’s credibility is further reinforced by its intellectual property portfolio of over 20 granted patents and recognition through multiple international industry awards. This established track record provided substantial evidence supporting the FDA’s clearance decision.

Technology Platform Redefines Treatment Approaches

The core innovation lies in the system’s ability to generate controlled plasma fields that produce therapeutic molecular species without traditional thermal effects. This mechanism enables:

• Sterilization capabilities for infection control and wound management
• Anti-inflammatory responses to reduce tissue inflammation and promote healing
• Tissue regeneration stimulation to accelerate natural repair processes
• Non-invasive treatment delivery suitable for sensitive patient populations

The technology represents what General Vibronics describes as a paradigm shift in therapeutic approaches, offering healthcare providers alternatives to more invasive treatment protocols.

Market Expansion Opportunities Emerge

The FDA clearance creates immediate opportunities for broader clinical integration across American healthcare systems. Medical facilities can now explore applications spanning multiple specialties, from dermatology and wound care to aesthetic medicine and regenerative therapies.

This regulatory approval enables the establishment of new clinical partnerships and research collaborations within the United States, potentially accelerating the development of additional applications and treatment protocols. The clearance also facilitates easier adoption by healthcare institutions that require FDA-approved devices for patient care.

Industry Impact and Future Developments

General Vibronics has acknowledged the contributions of their development team, international partners, and early-adopting healthcare professionals who provided clinical feedback during the technology’s development phase. The company credits these collaborative relationships as instrumental in achieving the regulatory milestone.

Moving forward, the organization plans to share additional clinical case studies and provide opportunities for American healthcare professionals to evaluate the technology’s capabilities. These initiatives aim to support informed adoption decisions and demonstrate real-world applications across various medical specialties.

The MIRARI Cold Plasma System’s FDA clearance represents more than a single product approval—it signals growing regulatory acceptance of plasma-based therapeutic technologies and their potential to enhance patient care through safer, more effective treatment options.

This development positions the technology to contribute to what the company describes as a global movement toward more accessible and effective healthcare solutions, with the American market now joining international healthcare systems in exploring cold plasma therapy applications.