Why is Red Light Therapy So Confusing and What Do the FDA Claims Mean?

Feeling frustrated about all of the conflicting information regarding red light therapy? Why is it so confusing and why don't all sellers disclosure the same information so the consumer can make an educated purchasing decision? After endless research and reading, studying to become a Certified Light Therapist, purchasing a multitude of red light devices to try, etc., I came to the decision to start my own business, Light Therapy Resource LLC in order break through all of this confusion and misinformation and offer affordable and effective light therapy devices in an honest way with the education, resources, and personalized support to get you the most from your device! I personally have experienced so much success utilizing light therapy to address issues my health care team were unable to address or could not diagnose that I want others to have the option as well! That is why all devices purchases from our store include access to our introductory light therapy course, so you aren’t left hanging after your purchase!

First, what is red light therapy? Red light therapy, also known as Photobiomodulation, utilizes specific wavelengths of red and near-infrared light to stimulate cellular function in the body. By interacting with cells, light therapy has the ability to promote improved circulation, tissue repair, reduced pain, inflammation, hair regrowth, and a variety of skin conditions. However, it has typically been extremely expensive, only available through an office setting or for home use to those who can afford devices in the tens of thousands of dollars. But in recent years, with the increase in awareness and resulting increase in demand for these devices, it has become more affordable and we are hearing more and more stories about the life changing benefits it can provide. However, the industry is fairly unregulated, leaving room for just about anyone to jump in, set up a storefront, and start selling devices from the overseas market. This leaves the consumer to fend for themselves.

In January of 2023, the FDA released draft guidelines for Photobiomodulation devices, which includes light therapy devices! And the list of research papers and studies being published on the different benefits of light therapy continues to grow so it's very exciting. But along with this comes the random Amazon sellers offering holiday light red light therapy devices with no real information or guidance about the device itself. And with so much misinformation and the vast range of pricing, it's difficult to know what to believe!

Now let's first talk about the devices themselves. You will see all sorts of false advertising and marketing ploys by sellers in an attempt to try to set their device apart as being the best (which is just an excuse to charge more, LOL). But these light therapy devices for sale in the U.S. are not approved by the FDA as that is not required, but rather they are cleared by the FDA. There is a big difference. Devices that are cleared by the FDA are subject to a 510(k) review and are then “cleared” for sale by the FDA. That is as far as it goes. And yes, our Light Therapy Resource devices have been through the 510(k) review by our supplier and cleared by the FDA. But the FDA does not regulate red light therapy devices.

And finally, what about these crazy claims about the facilities where the devices are manufactured. Companies are making claims that their devices are manufactured in an FDA-registered facility or they use FDA-cleared methods in manufacturing. Sound super official right? Well, they are completely meaningless and frankly it's false marketing. Any company or manufacturer can “register” its facility with the FDA for a fee. Facility registration and/or device listing does not imply the facility or device has been reviewed and approved by the FDA. The FDA makes this very clear to whoever registers and/or lists their products saying: “Please note that registering your device facility and listing your devices does not, in any way, constitute FDA approval of your facility or your devices”.

So buyer beware of misleading and false marketing claims, they are everywhere! My commitment as a seller in this industry is to be honest, ethical and transparent with all of my product offerings. We haven't even discussed what to look for specifically when comparing light therapy sellers and I could write an entire blog on this topic. In fact I have, read it here! But if you are not seeing the irradiance (energy output), frequencies (wavelengths being emitted), treatment coverage area, quality of the product (what is it made out of), and clear customer support information, walk away! Those are red flags, it should not be difficult to find any of this information and if it is, that means they are hiding something! All of the products on the Light Therapy Resource website have this information and I am also easily reachable for any questions or customer support issues. My company is also a registered LLC and a license reseller in the state of California. So buy with confidence! Click here to visit the product page. Do you have more questions about what is red light therapy and how it can help you? Chat 24 hours a day, 7 days a week with RosyBot, our automated assistant!