At Neuronic, we are committed to providing innovative wellness technology while maintaining transparency about what our devices are—and what they are not. Our Neuronic LIGHT Device is classified as a medical device, in the USA only, but it is not intended for the diagnosis, treatment, or prevention of any medical condition. This distinction is crucial, and we want to ensure that all users fully understand the scope and purpose of our product.
Why Our Device Is Classified as a Medical Device
The Neuronic LIGHT Device has been classified as a medical device under the ILY category by the FDA. This classification applies to therapeutic infrared lamps that are designed to emit energy in the near-infrared spectrum, which has been studied for its effects on biological tissue.
To achieve this classification, our device has undergone rigorous testing and meets international safety and quality standards, including:
- Manufacturing in ISO 13485–Certified Facilities – Our devices are produced in facilities that adhere to this internationally recognized standard for quality management systems specific to medical devices.
- ISO 10993 Biocompatibility Standards – Our device meets safety requirements regarding materials and skin contact, ensuring it is safe for regular use.
- Electromagnetic Safety Testing (IEC 60601-1, IEC 60601-1-2) – Ensures our device complies with medical electrical equipment safety standards, minimizing electromagnetic interference.
- FDA Registration Under ILY Classification – The FDA classifies therapeutic infrared lamps under ILY regulations, indicating their intended use for general wellness applications rather than disease treatment.
While these certifications demonstrate our commitment to safety, they do not imply that our device is a medical treatment. Instead, our focus remains on supporting wellness, relaxation, and cognitive function.
What This Means for You
While our device meets regulatory classifications under the ILY category, this does not mean we can or do make medical claims about its effects. The Neuronic LIGHT Device is designed to support general wellness, particularly in the areas of relaxation and cognitive function. However, it is not a substitute for medical care or professional healthcare guidance.
Our Legal Disclaimer
- Neuronic devices do not diagnose, treat, cure, or prevent any disease.
- Neuronic does not provide medical advice.
- Our products are designed to support overall wellness and should not replace professional medical guidance.
- Always consult a qualified healthcare professional for any health concerns or medical conditions.
- While many users report positive personal experiences, individual results may vary.
Why We Can’t Make Medical Claims
Photobiomodulation (PBM), the technology behind the Neuronic Light device, has been widely studied for its potential effects on brain function and cellular health. However, while research is promising, federal regulations require extensive clinical trials before a device can be marketed as a treatment for specific medical conditions. Until such trials are completed and regulatory approvals granted, we cannot and do not claim that our device treats any medical condition.
Empowering You to Make Informed Decisions
At Neuronic, we encourage education and informed decision-making. The field of light-based wellness technology continues to evolve, and we support ongoing research into PBM’s applications. Whether you are interested in the science or simply looking for a wellness tool, we recommend:
✔️ Exploring reputable research on photobiomodulation.
✔️ Consulting with healthcare professionals before starting any new wellness practice.
✔️ Using the device as directed in the user manual for best results.
We remain committed to delivering high-quality, research-backed wellness technology while adhering to the highest ethical standards.
For more information, visit Neuronic Online or contact us directly.
