What Red Light Therapy Devices are FDA Approved?

The FDA or Food and Drug Administration is a federal agency responsible for protecting public health by ensuring product efficacy and safety. The Center for Devices and Radiological Health, a portion of the FDA, reports it oversees approximately 175,000 medical devices and receives over 22,000 premarket submissions for review. While at times cumbersome, the review processes are essential in minimizing risk and ensuring public safety.

With all the complicated lingo seen in FDA approval processes, it’s tough to know how to interpret the language and use it to make sound medical device decisions. Follow along as we unpack the modality of red light therapy, its journey through the FDA approval process, and associated terminology.

The Difference Between “Cleared”, “Registered”, and “Approved”

When it comes to the FDA, there are several terms thrown around that are used to describe various levels of approval. As it relates to red light therapy, the skinny is that the treatment as a whole poses a low risk to the public therefore related products do not need to go through the pre-market approval process before hitting the shelves. Some products may be advertised as ‘cleared’ or ‘registered’ by the FDA meaning the device has gone through a review process known as 510(k) and indicates the product is similar to legally available products and offers a comparable level of risk. While the process is far less complex, these clearance processes protect the public by providing a preliminary assessment and validating that the item is a ‘low-risk’ product that is safe for individual application. 

Without a specific and thorough approval process, it can be helpful to rely on other methods of research to make informed buying decisions. Leaning on trusted brands and gaining knowledge of intended use and product offerings can enhance your decision-making process. Having a grasp of therapeutic wavelengths and appropriate intensities for your condition will help you choose the most optimal device and reap the greatest benefits of the modality. This said, with increasing transparency and widespread reviews, you can rest assured that when used appropriately, the therapy is considered both safe and effective for a number of ailments and conditions. 

So, Does Red Light Therapy Pose Any Risk?

As touched on before, there is little to no risk of red light therapy when used correctly. There have been a few incidents reported of localized burns or blistering due to falling asleep while the product was applied, but most complications reported were caused by user error versus inherent product risk. Outside of these unique circumstances, red light therapy has been proven safe and non-invasive.

Our Top Best FDA-Cleared and FDA-Registered Red Light Therapy Devices

Best Red Light Therapy Bed

The Prism Light Pod Red Light Therapy Bed is one of the top-rated and most impressive red light therapy devices on the market today. Offering total-body exposure with more than 14,000 LEDs, it can efficiently and effectively deliver therapeutic light that contributes to pain relief, skin enhancement, wound healing, and muscle recovery. 

With the touch of a button, light energy is transmitted at wavelengths of 630nm, 660nm, and 850nm, producing therapeutic benefits in only 15-minute targeted treatment sessions. Along with the world-class device comes an included Pro-Partner Joint Marketing Program, which outlines effective marketing, co-branding, and operational strategies to make the most of your product use.

Best Red Light Therapy Full-Body Pad

Prism Light Pad | Full Body Red Light Therapy View Product

If full body treatment is your goal but portability is key, the Prism Light Pad offers users comprehensive light exposure in the convenience of a portable pad. Measuring 72 inches by 35 inches, it is the largest pad of its kind on the market and can cover almost any body type. Used as either a blanket or pad, you can experience the benefits of more than 2200 red and near-infrared LEDs in 30-minute automated treatment sessions. 

Weighing in at only 6 lbs, the Prism Light Pad was created with convenience and transport in mind. Rolling up into an included travel bag, the pad can be applied in the comfort of your home, at the office, or even on vacation. With simple sanitation options, it’s one of the most versatile red light therapy options for clinicians and home users alike.

Best Red Light Therapy Wrap

LED and Infrared Light Therapy Body Pad with Straps | DPL Flex Pad View Product

For those in search of a more targeted application, the dpl Deep Penetrating Infrared FlexPad Light Therapy System emits its benefits in the comfort of a wrap application. Applicable to any body part, the wrap uses medical-grade red and near-infrared LEDs to enhance circulation, promote pain relief, improve collagen production, and expedite wound healing. 

With flexible use in mind, the dpl FlexPad Light Therapy system was created to accelerate healing no matter where life takes you. With standard outlet and USB charging options, you can be sure your device will be ready when you need it and the hands-free application allows you to complete treatments while carrying on your daily activities. 20-minute applications are all you need to start reaping the therapeutic benefits of red and near-infrared light exposure.

Best Handheld Red Light Therapy Device

Medlight 630 Pro Hand Held Red Light Therapy View Product

Finally, for the most compact red light therapy option, look no further than the Medlight 630 Pro handheld red light device. This innovative handheld option uses 81 LEDs and integrated technology to produce near-infrared energy that contributes to pain relief, circulatory benefits, and skin and muscle healing. 

The included spacer rings set the optimal treatment distance ensuring you are getting a safe and efficient dose of light energy. The device is comfortable to hold, offers a simple and streamlined application, and boasts cumulative effects with prolonged product use. 

Final Thoughts

Red light therapy is a non-invasive and safe modality that continues to gain popularity for its anti-inflammatory, anti-aging, and healing properties. With FDA approval for the treatment as a whole, you can rest assured the therapy is effective with appropriate use. Relying on trusted brands and doing your research to ensure optimal treatment parameters are essential to reaping the greatest therapeutic outcomes from this ‘glowing’ treatment.

For more information relating to red light therapy and similar modalities, we invite you to explore Caregiver University, our expert-curated content portal that helps caregivers and practitioners make the most informed medical-device purchases. Check out our full listing of Light Therapy products for sale and get ready to join the millions of users that are experiencing the valuable effects of light therapy.