The Mirari Cold Plasma System is approved by the Thai FDA,Vietnam MOH and FDA-Cleared in the United State for specific uses. The testimonials and content presented here are for informational purposes only. Always consult with a healthcare professional before considering any treatment or procedure. The Mirari Cold Plasma System is approved by the Thai FDA,Vietnam MOH and FDA-Cleared in the United State for specific uses. The testimonials and content presented here are for informational purposes only. Always consult with a healthcare professional before considering any treatment or procedure.

Disclaimer

Last Updated: October 19, 2026

1. General Information and Corporate Identity

This website, www.MIRARIdoctor.com (the “Website”), is owned and operated by MIRARI Doctor Pte. Ltd. (“MIRARI Doctor,” the “Company,” “we,” “us,” or “our”), a private limited company incorporated and registered under the laws of the Republic of Singapore.

MIRARI Doctor serves as the authorized International Master Distributor of the MIRARI® Cold Plasma System and related products manufactured by General Vibronics, Inc. (“General Vibronics”), USA, within its contractually designated territories outside the United States of America.

MIRARI Doctor’s international activities include commercial distribution, authorized distributor relationships, market development, product education, and regulatory coordination, subject to applicable contractual rights and local regulatory requirements.

All content on this Website, including text, graphics, images, videos, research summaries, clinical information, treatment descriptions, and product specifications, is provided for general informational and educational purposes only.

Nothing on this Website constitutes professional medical advice, diagnosis, treatment, or an independent authorization to use a medical device.

2. Medical Device Disclaimer — FDA-Cleared Intended Use and Indications for Use

The MIRARI® Cold Plasma System (GV-M2-01) is designed and manufactured by General Vibronics, Inc., USA, and distributed internationally by MIRARI Doctor within its authorized territories.

The device received clearance from the U.S. Food and Drug Administration (FDA) on November 21, 2024, under 510(k) K242553, as a Class II medical device regulated under 21 CFR 878.4400.

FDA-Cleared Indications for Use

The FDA-cleared indications for use state:

“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.”

Strict Intended-Use Limitation

MIRARI Doctor Pte. Ltd. adopts the FDA-cleared intended use and indications for use as the governing limitation for its commercial representations, product promotion, distribution activities, and authorized product training, subject to any narrower restrictions imposed by applicable local regulatory authorizations.

The MIRARI® Cold Plasma System shall be promoted, distributed, and represented by MIRARI Doctor and its authorized commercial partners solely for its FDA-cleared intended use and indications for use, and only where permitted by applicable local law.

MIRARI Doctor does not authorize or endorse the promotion of the device for additional therapeutic indications, disease-specific treatments, or clinical outcomes beyond the FDA-cleared labeling unless such uses have received the necessary regulatory authorization and the applicable manufacturer-approved labeling has been updated.

The device is not represented as FDA-cleared for wound healing, tissue regeneration, antimicrobial treatment, hair restoration, or other applications outside its cleared indications.

Professional Use and Operating Restrictions

The device is intended for prescription use in accordance with its applicable FDA-cleared labeling. It must be operated in compliance with the manufacturer’s current instructions for use, including applicable operator qualifications, training requirements, contraindications, precautions, and treatment parameters.

MIRARI Doctor does not authorize self-diagnosis, unauthorized self-treatment, or operation inconsistent with the applicable product labeling.

Geographic Regulatory Limitation

U.S. FDA clearance applies to the United States and does not constitute regulatory approval, registration, or authorization in Singapore or any other jurisdiction.

In international markets, product promotion, supply, and use must comply with both MIRARI Doctor’s intended-use limitations and the applicable local regulatory authorization. Where local requirements are more restrictive, those requirements shall prevail.

3. International Master Distribution and Territorial Rights

MIRARI Doctor operates as the designated International Master Distributor for MIRARI® products in territories outside the United States, to the extent authorized by its applicable distribution agreements.

Its activities may include developing distributor networks, coordinating product supply, providing product education, and supporting regulatory and commercial market-entry activities.

  • All distribution rights are subject to contractual territorial limitations, applicable laws, import and export controls, medical-device registrations, and distributor licensing requirements.
  • Master Distributor status does not establish regulatory authorization in any particular country.
  • No information on this Website constitutes an offer to sell or distribute a medical device in a jurisdiction where the necessary regulatory permissions have not been obtained.
  • All authorized distributors and commercial partners are expected to comply with the applicable manufacturer-approved labeling and refrain from making unsupported or unauthorized therapeutic claims.

4. Not a Substitute for Professional Medical Advice

The medical, scientific, technical, and educational content published on this Website is not intended to replace advice, diagnosis, or treatment provided by qualified healthcare professionals.

Visitors should consult an appropriately licensed healthcare professional regarding medical conditions, treatment options, and the suitability of any medical device.

  • Do not disregard professional medical advice based on information obtained from this Website.
  • Do not delay seeking medical attention because of Website content.
  • Do consult a qualified healthcare professional before beginning, changing, or discontinuing any medical treatment.

Access to this Website does not establish a physician-patient relationship or other healthcare-provider relationship with MIRARI Doctor.

5. Clinical Information, Therapeutic Claims, and No Guarantee of Results

The MIRARI® Cold Plasma System incorporates radiofrequency (RF) energy and dielectric barrier discharge (DBD) technology.

The device’s authorized therapeutic claims are limited to its applicable cleared or locally authorized indications, including therapeutic heating for temporary pain relief, relief of muscle spasms, and increased local circulation as described in FDA 510(k) K242553.

Descriptions of RF technology, cold atmospheric plasma, dielectric barrier discharge, or associated physical and biological mechanisms are provided for scientific and technical education only. Such descriptions must not be interpreted as evidence of FDA clearance or regulatory authorization for additional therapeutic indications.

Scientific publications, preclinical studies, investigational research, and emerging clinical applications discussed on this Website do not expand the device’s cleared intended use or establish that MIRARI® has been authorized to treat any additional disease or condition.

MIRARI Doctor does not guarantee any particular therapeutic outcome, clinical improvement, or treatment result. Individual responses may vary depending on medical history, clinical condition, treatment parameters, and other patient-specific factors.

Clinical decisions, patient evaluation, treatment planning, and monitoring remain the responsibility of appropriately qualified healthcare professionals.

6. Limitation of Liability

To the fullest extent permitted by applicable law, MIRARI Doctor Pte. Ltd., its directors, officers, employees, representatives, and agents disclaim liability for losses or damages arising from or relating to:

  • Access to, use of, or inability to access this Website.
  • Errors, omissions, inaccuracies, or outdated Website information.
  • Reliance on medical, scientific, technical, or commercial information provided through this Website.
  • Website interruptions, technical failures, or unauthorized interference.
  • Content or services provided by independently operated third-party websites.

To the extent permitted by applicable law, MIRARI Doctor shall not be liable for indirect, incidental, special, consequential, or punitive damages arising from use of this Website.

Nothing in this Disclaimer excludes or limits any liability, statutory right, or legal remedy that cannot lawfully be excluded or restricted, including liability for death or personal injury caused by negligence where such exclusion is prohibited.

This Disclaimer relates to Website content and use and does not replace applicable product warranties, sales agreements, consumer protection obligations, product liability requirements, or other legally enforceable responsibilities.

7. Regulatory Compliance and Jurisdictional Notice

Medical devices are subject to country-specific regulatory requirements concerning registration, importation, distribution, advertising, labeling, and clinical use.

In Singapore, medical devices are regulated by the Health Sciences Authority (HSA) under applicable medical-device legislation.

  • Regulatory clearance or authorization in one jurisdiction does not automatically authorize marketing, distribution, or use in another jurisdiction.
  • MIRARI Doctor maintains the FDA-cleared intended use as the baseline limitation for its international product representations, subject to any narrower local regulatory authorizations.
  • Neither MIRARI Doctor nor its authorized distributors may represent the MIRARI® Cold Plasma System as authorized for additional medical indications without the necessary regulatory authorization.
  • Prospective purchasers, distributors, and healthcare professionals must verify applicable regulatory status and product availability before purchasing, importing, distributing, or using the device.

8. Use by Healthcare Professionals

Technical, clinical, and treatment-related information on this Website is intended primarily for appropriately qualified healthcare professionals and authorized commercial partners.

Healthcare professionals operating the MIRARI® Cold Plasma System must:

  • Satisfy applicable professional qualification and training requirements.
  • Follow the manufacturer’s current instructions for use, including contraindications, warnings, precautions, and operating parameters.
  • Use the device only for purposes permitted by applicable product labeling and regulatory requirements.
  • Exercise independent professional judgment when evaluating patient suitability and determining treatment protocols.

Information provided on this Website does not authorize operation of the device outside applicable regulatory or professional requirements.

9. Online Store, Distribution Inquiries, and Third-Party Websites

Products and services offered through store.MIRARIdoctor.com are subject to the applicable terms of sale, purchase conditions, shipping restrictions, warranties, and other published policies.

Online availability does not establish authorization to purchase, import, distribute, or use a medical device in any jurisdiction where additional regulatory requirements apply.

This Website may include links to third-party websites, including those operated by General Vibronics and independent scientific or commercial organizations. MIRARI Doctor does not control independently operated third-party websites and does not warrant their accuracy, completeness, availability, or reliability.

10. Intellectual Property and Trademarks

The MIRARI® name, related trademarks, product names, logos, and other intellectual property displayed on this Website belong to their respective owners or authorized rights holders. MIRARI Doctor uses applicable trademarks and product-related intellectual property pursuant to its contractual rights or authorizations.

Except as permitted by law or with prior written authorization, visitors may not reproduce, distribute, modify, or commercially exploit protected Website materials or trademarks without the appropriate rights holder’s consent.

Nothing on this Website grants ownership of, or a license to use, any trademark, patent, copyright, trade secret, or other intellectual property.

11. Governing Law and Jurisdiction

Subject to applicable mandatory laws and statutory rights, this Disclaimer shall be governed by and construed in accordance with the laws of the Republic of Singapore.

To the extent permitted by applicable law, disputes arising from or relating to this Disclaimer or use of this Website shall be subject to the exclusive jurisdiction of the courts of Singapore.

Nothing in this provision shall restrict rights or protections that cannot lawfully be waived under applicable consumer protection or other mandatory laws.

12. Amendments and Updates

MIRARI Doctor reserves the right to revise or update this Disclaimer, Website content, product information, and regulatory disclosures from time to time. Changes will become effective upon publication unless otherwise stated or required by applicable law.

Visitors are encouraged to review this Disclaimer periodically.

13. Contact Information

For questions concerning this Disclaimer, international distribution, product availability, or regulatory information, please contact:

MIRARI DOCTOR PTE. LTD.
600 North Bridge Rd #13-01
Parkview Square, Singapore 188778
Email: contact@MIRARIdoctor.com
Website: https://miraridoctor.com
Singapore UEN: 202327566E
Registration Date: 13 Jul 2023