FREQUENTLY ASKED QUESTIONS

REGULATIONS
 

The devices have been tested for electrical safety and rendered safe by TUV Rheinland standards. It consumes and generates less energy than most consumer electronic devices, and the energy cannot be felt by a normal person. They are compliant with the European CE requirements for safety.

They have been evaluated by the FDA and Health Canada as low-risk general wellness devices. We are currently in the process of verifying the efficacy of our research-grade devices with several universities and government research bodies through a large scale clinical trial. Hence, we do not make claims for long-term cures.

Why the Vielight 655 and Pocket Miracle can no longer be sold in the United States?

Because Vielight 655 and the Pocket Miracle are laser products.  All laser products now require FDA approval.  Since Vielight has yet to apply for FDA Approval of their laser products (655 Prime and Pocket Miracle), they can no longer supply or sell them in the United States. However, these laser products are available for purchase outside of the United States.

The final FDA Regulation on General Wellness Devices was released recently here.

The rest of the Vielight products are low-risk general wellness products that do not require FDA clearance.

All Vielight devices have been independently TÜV certified as safe for consumer use.

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