MIRARI® Cold Plasma System
FDA-Cleared Cold Plasma Technology by General Vibronics
The MIRARI® Cold Plasma System designed and manufactured by General Vibronics, received U.S. Food and Drug Administration (FDA) 510(k) clearance in November 2024 marking a significant milestone in its validation for medical use.
Read DisclaimerSimple 4-Step Process
We verify credentials before every purchase to comply with federal Rx requirements.
Apply with Your NPI
Enter your NPI — your details are filled in from the national NPI registry. Add your license and contact details.
Credential Verification
Our compliance team verifies your credentials with primary sources: NPPES, your state licensing board, OIG and SAM.gov.
Training & Enrollment
Complete the online MIRARI® training and sign the Part II enrollment form electronically in the Provider Portal.
Order & Delivery
Place orders in the portal and pay online or by bank wire. Each device ships with full documentation, serial number and UDI tracking.
Important Notice
Prescription Device: The MIRARI® Cold Plasma System is an FDA 510(k) cleared (K242553) Class II medical device. Federal law restricts this device to sale by or on the order of a licensed healthcare professional. MIRARI® Cold Plasma System is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Purchase Requirements: An active and valid NPI number and state license are required for verification prior to order processing. All orders are fulfilled through a manual review process to ensure compliance with Medicare enrollment/PECOS, OIG exclusion and SAM.gov and NPDB (when eligible/required).
Disclaimer: This website is intended for licensed healthcare professionals in the United States. The information provided does not constitute medical advice. Refer to the Instructions for Use for complete safety and prescribing information. MIRARI® is a registered trademark of General Vibronics, Inc.