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* In the European Union, the intended use of the Luminousred LED Light Therapy system does not fall within the scope of article 2 section 1 of 2017/45 mdr.
Thus it is not a medical device.
Thus it is not a medical device.
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The statements on this website have not been evaluated by the FDA (U.S. Food & Drug Administration). Our products are not intended to diagnose, treat, cure, or prevent any disease. Our products are low-risk, general wellness / fitness products that do not require FDA clearance, in accordance with the “General Wellness: Policy on Low Risk Devices” draft released January 20, 2015.
