Regulatory Information
Regulatory Status
The MIRARI® Cold Plasma System is a prescription medical device.
- Device: MIRARI® Cold Plasma System (Model GV-M2-01)
- Regulatory Pathway: FDA 510(k) Premarket Notification
- 510(k) Number: K242553
- Device Class: Class II
- Regulation Number: 21 CFR 878.4400
- Product Codes: PBX, GEI
- Type of Use: Prescription Use — Rx Only
Indications for Use (as cleared by FDA):
MIRARI® Cold Plasma System provides 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.
The Product may be promoted and sold only consistent with applicable law and its applicable regulatory status and labeling.
For the FDA's public record of this clearance, see the FDA 510(k) Premarket Notification Database — K242553.
Important Notices
FDA clearance does not constitute endorsement by the U.S. Food and Drug Administration.
Nothing contained on this website is intended to expand, replace, modify, or supersede the Product's current FDA-cleared indications, labeling, Instructions for Use, warnings, precautions, or contraindications.
In the event of an inconsistency between general website information and the current manufacturer-issued labeling or IFU, the applicable Product labeling and IFU shall control.
Professional Medical Judgment
Information presented on this website does not constitute individual medical advice, diagnosis, or treatment and is not a substitute for independent professional medical judgment.
Patient selection, diagnosis, treatment planning, prescription, supervision, and clinical decisions regarding use of the MIRARI® Cold Plasma System remain the responsibility of the appropriately licensed treating practitioner.
GVI does not practice medicine through this website or through the sale of the Product.
No website content should be interpreted as directing treatment for a particular patient.
Clinical Outcomes
Individual patient responses and clinical outcomes may vary.
No particular clinical outcome, therapeutic response, duration of benefit, or patient-specific result is guaranteed except to the extent expressly represented in applicable Product labeling.
Testimonials, case reports, demonstrations, educational materials, or descriptions of individual experiences, if presented, should not be interpreted as guarantees that another patient will experience the same result.
Product Claims
Product performance, clinical, scientific, and safety statements appearing on this website are intended to be consistent with applicable regulatory requirements and supported by appropriate evidence.
No distributor, reseller, sales representative, purchaser, healthcare provider, or other third party is authorized by GVI to modify GVI's approved marketing materials or make unauthorized, false, misleading, or unsubstantiated representations concerning the Product.
Third-party statements do not constitute representations of GVI unless expressly adopted by GVI in writing.