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Does FDA Approval Matter When Choosing An Light Therapy Mask

When considering whether to purchase an LED light therapy device, you may wonder if FDA approval is a “make or break” requirement. The answer is, sometimes it is. It’s important to understand the difference between FDA approval, clearance, and FDA registration, and be skeptical of brands that use these terms interchangeably, as they are not the same thing.

Read on for a brief introduction to the FDA approval process and tips for choosing the perfect LED light therapy mask for you.

What is the FDA?

The FDA (Food and Drug Administration) is a federal agency within the U.S. Department of Health and Human Services. It is part of the U.S. government and is responsible for protecting and promoting the public health by regulating certain product categories such as food, drugs, medical devices, tobacco products, and electronic products that emit radiation, such as ultrasound therapy devices.


How does the FDA regulate medical devices?

The FDA regulates LED light therapy devices because they claim medical and cosmetic benefits. These benefits include inflammation, wound healing, scar healing, reducing acne-causing bacteria, and treating dermatitis, eczema, psoriasis, rosacea. Therefore, they are reviewed through multiple FDA regulatory channels. The FDA uses what is called a “risk-based tiered approach” to regulate medical devices. This means that they regulate devices based on how risky they are to the public.

Let’s break down what this means.

What is FDA Approval?

The “FDA Approval” process regulates the highest risk category of devices, also known as Class III devices. These devices include defibrillators, implantable pacemakers, cochlear implants – and importantly, do not include LED light therapy devices – so if you’ve ever seen an “FDA-approved” LED light therapy mask, it’s a misnomer.

Class III devices require FDA approval before they can be marketed. Manufacturers must establish satisfactory, scientifically based criteria to provide “reasonable assurance that the device is safe and effective.”


What is FDA Clearance?

Moderate risk medical devices (Class II) require FDA clearance, including power wheelchairs, blood pressure cuffs, contact lenses, syringes, LED light therapy devices, and IPL hair removal devices. Manufacturers must demonstrate that their device is “substantially equivalent to a lawfully marketed similar device that does not require premarket approval.” In short, there are similar devices already on the market. Manufacturers use the 510(k) process to review Class II products.

So, as we said before – an LED light therapy device cannot be “FDA-approved” because it does not meet the risk category associated with this regulatory requirement. Therefore, if an LED light therapy device has gone through this process, it is considered “FDA approved.” It is important not to view FDA approval as an “inferior” or “less safe” regulatory process, it is simply a different review process based on the specific risks presented by the device.


What is FDA registration?

FDA registration simply means that a company has registered with the FDA, provided company information, and has products listed on the FDA website. Essentially, as a consumer, don’t pay too much attention to this.

Should LED masks be FDA approved?

The questions are endless when you’re trying to decide which LED mask you should invest in. How do I know if my LED mask is FDA approved? Which LED light brands are FDA approved? Or importantly, should LED masks be FDA approved?

As we’ve said, but we’ll state it again because it’s important, LED light therapy devices cannot be FDA approved – it’s definitely a brand red flag if they make these claims, whether intentionally or not, which can indicate a lack of knowledge on the subject.

When it comes to FDA approval, however, the color of the LED plays a big role in whether or not a device is FDA approved. Red, blue, and infrared light therapy are FDA approved – but other LED colors on the visible spectrum are not.

That’s why you may notice that devices containing green, yellow, violet, cyan, or white light will not be FDA-approved. There are several studies that prove their effectiveness, but they have not gone through the approval process to date. For these colors, it’s important to look for third-party safety verification, such as the CE mark. This ensures that the product is safe for home use.


Is red light therapy FDA approved?

No, but it is FDA approved. If your device has only red light, or any combination of red, blue, and infrared light, it is FDA approved, and so it should be. FDA approval of blue, red, and infrared devices ensures that they meet the highest standards of safety and effectiveness and are approved for home use. The FDA defines red LED light therapy as “over-the-counter light-based wrinkle reduction” that “uses light-based energy delivered to or through the skin to modify tissue in order to reduce wrinkles”

The FDA defines blue light therapy as “over-the-counter light-based lasers for acne.” These descriptions back up the claims made by LED light therapy mask retailers about the benefits of red and blue light for fighting aging and acne, respectively.

Why are some LED light therapy devices FDA approved and others not?

Red, blue, and infrared light therapy devices are FDA approved – it’s because the FDA regulates any “medical claims” made by device manufacturers. Blue, red, and infrared light have been used as medical treatments for decades. The purported benefits of infrared, blue, and red light therapy can technically be described as medical benefits.


Why is my 7-color LED light therapy mask not FDA approved?

While many studies have shown that yellow, green, purple, white and cyan light therapy are effective in providing cosmetic benefits, they have not been used in medical treatments to the same extent as red, blue and infrared light. As a result, they have not been the subject of an FDA approval or clearance process to date. In fact, any LED device with therapeutic colors other than red and blue will not be approved by the FDA.

The FDA’s approval and clearance process is an ever-changing one, with some devices moving from Class II to Class III and some being newly introduced into the approval and clearance process, so it is not unlikely that other visible light therapies will someday require FDA approval.

Key Point: Are home LED light therapy devices safe and effective?

FDA approval is important for infrared, blue and red LED light therapy masks. Approval demonstrates their safety and efficacy in fully rejuvenating the skin, including controlling acne, anti-aging and healing and regenerative processes, among other claims.

Because purple, green, yellow, cyan and white LED light therapy devices are not used in medicine to the same extent as red, blue and infrared, they have not been the subject of the FDA’s approval process to date, but of course, that may change in the future.

FDA approval may be a priority when choosing the perfect LED light therapy mask for you, and there are many excellent options that meet this criteria, but if you are looking to treat a wider range of skin conditions, a 7-color LED light mask may be the right choice for you.



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