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Is red light therapy approved by FDA?

Red light therapy is taking the health and wellness world by storm, with compelling research backing up benefits like reduced inflammation, accelerated healing, and rejuvenated skin. But with the rise in popularity of at-home red light devices, how can you be sure you’re getting an effective and safe treatment? FDA approval provides that validation, yet confusion persists around its status for red light therapy. Let’s shed light on what red light therapy is, The Importance of FDA Approval for Red Light Therapy Devices, and how to choose a compliant device.

FDA red light therapy

What is red light therapy and how does it work?

Red light therapy, also known as low-level laser therapy or photobiomodulation, is a non-invasive, painless therapy that uses red and/or near-infrared light to stimulate the body’s natural healing processes. It works by exposing the skin and other tissues to red and near-infrared light wavelengths, typically between 600 and 1000 nanometers. These wavelengths are able to penetrate the skin and reach the underlying tissues, where they stimulate the production of ATP (adenosine triphosphate), which is the primary source of energy for cells.[1]

This increase in ATP production helps to optimize cellular function and improve cellular metabolism, which can lead to a range of therapeutic benefits. Specifically, red light therapy has been shown to help reduce inflammation, increase circulation, enhance collagen production, and promote tissue repair and regeneration. Red light therapy can be administered using a variety of devices, including LED panels, handheld devices, and full-body light beds. It is commonly used to treat a variety of conditions, including arthritis, joint pain, muscle soreness, skin conditions, and more. It is also used in beauty treatments to improve skin tone and reduce the appearance of fine lines and wrinkles.

What is the FDA?

The Food and Drug Administration (FDA) is a renowned regulatory agency in the United States responsible for protecting public health by ensuring the safety and efficacy of medical devices, drugs, and other products. Their rigorous approval process evaluates the benefits, risks, and scientific evidence associated with each device. FDA approval is a significant milestone as it assures consumers that a particular product meets the highest standards of quality and safety.

What is the FDA?

Is red light therapy approved by FDA?

Yes, red light therapy is indeed approved by the FDA. FDA clearance signifies that specific red light therapy devices have undergone comprehensive testing and analysis to ensure their safety and efficacy. When considering red light therapy, it is crucial to choose an FDA-approved device to maximize the benefits and minimize any potential risks.

The benefits of using an FDA-approved red light therapy device

Opting for a red light device or panel that has gained FDA clearance for treating certain conditions provides key advantages:

– Confidence in a proven, compliant medical technology.
– Assurance the light wavelengths, output and parameters are optimized and effective.
– Following best practice guidelines for treatment durations and frequencies.
– Often backed by a company with years of experience and clinical testing.
– Frequently come with generous return policies and warranties.
– Indication the technology underwent rigorous review and passed.

Seeking FDA clearance gives consumers greater certainty in the safety and performance of a red light therapy system or tool. Approval signifies it meets established therapeutic standards.

the effectiveness of FDA-approved red light therapy devices

The effectiveness of FDA-approved red light therapy devices is backed by a wealth of scientific research and studies. Numerous clinical trials have demonstrated their positive impact on various conditions, including:

1. Acne Treatment: Red light therapy has been shown to reduce acne lesions and inflammation, providing a gentle and effective alternative to traditional acne treatments.[2]

2. Hair Growth Stimulation: Studies indicate that red light therapy can stimulate hair follicles, leading to increased hair growth and improved hair density.[3]

3. Pain Management: Research has highlighted the analgesic effects of red light therapy, making it a promising modality for chronic pain management.[4]

4. Rehabilitation and Physical Therapy: Red light therapy has been incorporated into rehabilitation programs to accelerate recovery, reduce muscle fatigue, and improve range of motion.[5]

How to Get FDA Approved LED Light Therapy Devices?

While not all red light therapy systems have full FDA medical device approval, opting for one with FDA clearance for specific purposes helps ensure you get an effective, compliant device. Additionally, when seeking an FDA-approved LED light therapy device, it’s essential to do your research and choose a reputable manufacturer. Look for products that explicitly state FDA clearance or approval on their packaging or website. Reddot LED is the top choice for your wellness journey.

Reddot LED is a manufacturer with 13 years of professional infrared and red light therapy device manufacturing experience. Their cutting-edge LED technology harnesses the healing power of red and near-infrared light, delivering effective treatment for a healthier, more radiant you. With an FDA-approved, Reddot LED red light therapy device have been vetted for safety and efficacy. Their red light therapy panels are trusted by consumers, estheticians, clinics, and medical offices alike.



FDA-approved red light therapy devices offer a safe, effective, and convenient path to wellness. With their scientifically proven benefits, these devices have the potential to transform your life by improving your skin health, alleviating pain, enhancing your mood, and promoting overall well-being. Experience the transformative benefits of red light therapy with total confidence in Reddot’s FDA-approved devices. Unlock your body’s natural ability to heal and feel your best with the proven power of red light.


[1]Photobiomodulation. American Society for Laser Medicine and Surgery. Accessed 2/21/23.

[2]Li, J, Li, J, Zhang, L, et al. Comparison of red light and blue light therapies for mild-to-moderate acne vulgaris: A randomized controlled clinical study. Photodermatology Photoimmunology & Photomedicine. 2022;38:459– 464.

[3]Pinar Avci, Gaurav K. Gupta, et al. Low-level laser (light) therapy (LLLT) for treatment of hair loss. Lasers Surg Med. 2014 Feb; 46(2): 144–151.

[4]Brosseau L, Welch V, et al. Low level laser therapy for osteoarthritis and rheumatoid arthritis: a meta-analysis. The Journal of Rheumatology. 2000 Aug.

[5]Lucio Santos Borges, Mikhail Santos Cerqueira, et al. Light-emitting diode phototherapy improves muscle recovery after a damaging exercise. Lasers in Medical Science volume 29, pages1139–1144 (2014).

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