Are Luminousred products approved by the FDA?

No, the Luminousred LED Light Therapy products fall under the low risk and general wellness categories, which do not require FDA registration as described in the “General Wellness Policy on Low Risk Devices” issued by the FDA on July 29, 2016.

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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.

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.

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Are Luminousred products approved by the FDA?

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