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Photobiomodulation Equipment and Training - THOR Photomedicine

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NovoTHOR Whole Body Light Pod

Low Level Laser LLLT Cold Laser Photobiomodulation Safety

Regulations differ from one country to the next.
In the USA the regulations can differ between states.
Regulations can differ between professions also.

There are regulations for manufacturers regarding safety and efficacy claims. Some countries have a formal application and approval process.

In some countries there are regulations for users. These usually determine which professions can operate a medical laser and what is considered a safe environment. These may not affect the use of LED treatment probes.

Here are some useful links that may help you understand the regulations in some countries:

UK Healthcare commission scope Scope for registration
UK Independent Healthcare Advisory Services Essential requirements
UK Independent Laser Safety Advisors Essential standards
UK Medicines & Healthcare Products Regulatory Agency MHRA
   
USA Independent Laser Safety Advisors USA Rockell Laser Institure
USA Independent Laser Safety Advisors Laser Training Institute
   
Canada - Health Canada Health Canada
   
Australia - Therapeutic Goods Administration Therapeutic Goods Administration


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THOR Photomedicine Ltd is an ISO 13485:2016 certified medical device company.

The THOR LX2.3 Photobiomodulation system has a medical CE mark (EC certificate). It is indicated for oral mucositis, tendinopathies, joint pain, neck pain and back pain for marketing in the UK, EU and Australia.

The THOR LX2.3 Photobiomodulation system is also FDA Cleared for marketing in the United States for: Temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

Excluding the THOR LED Helmet, THOR LX2 and NovoTHOR systems are manufactured under conditions fulfilling the quality system requirements of Annex II, excluding (4), of the directive 93/42/EEC as amended and satisfy the applicable international harmonised standards.

Positive systematic reviews published by:

The British Medical Journal (BMJ), The Lancet, the International Association for the Study of Pain (IASP), the World Health Organisation (WHO), the Multinational Association for Supportive Care in Cancer (MASCC), the European Society for Medical Oncology (ESMO)

Appropriate regulatory clearance or approvals include:

Quality certificates

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