Does FDA Approval Matter When Choosing an LED Light Therapy Mask?

Estimated reading time: 7 minutes

IN THIS ARTICLE:

• 01 What is the FDA?
• 02 How does the FDA Regulate Medical Devices?
• 03 What is FDA-Approval?
• 04 What is FDA-Clearance?
• 05 What is FDA-Registration?
• 06 Should LED Masks be FDA-Cleared?
• 07 Is Red Light Therapy FDA-Approved?
• 08 Why are Some LED Light Therapy Devices FDA-Cleared and Others Are Not?
• 09 Why is my 7 Color LED Light Therapy Mask Not FDA-Cleared?
• 10 The Takeaway: Are At-Home LED Light Therapy Devices at Home Safe and Effective?

When considering whether to purchase an LED light therapy device, you may be wondering if FDA approval is a ‘make or break’ requirement. The answer is, sometimes. It is important to understand the difference between FDA-approval; clearance and FDA registration and be skeptical of brands who use these terms interchangeably, because they are not the same thing. Despite the misconceptions, FDA-approved red light therapy masks are not a thing.

Keep reading for a whistle-stop tour of FDA approval procedures 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 of the Department of Health and Human Services. It exists under the ambit of the US government and is responsible for protecting and promoting public health by regulating certain product groups such as food, drugs, medical devices, tobacco products and electronic products giving off radiation e.g. ultrasonic therapy equipment.

How does the FDA Regulate Medical Devices?

The FDA regulates LED light therapy devices as they claim to provide medical, as well as aesthetic benefits.These include inflammation, wound healing, scar healing, reducing acne causing bacteria and treating dermatitis, eczema, psoriasis, rosacea. They are therefore scrutinized through the FDA’s multiple regulatory channels. The FDA uses what is known as a ‘risked-based, tiered approach’ for regulating medical devices. This means they regulate the devices according to the level of risk they represent to the public.

Let’s break down what that means.

What is FDA-Approval?

‘FDA approval’ procedures regulate the highest risk category of devices, also known as Class III devices. These include defibrillators, implantable pacemakers, cochlear implants - and importantly not LED light therapy devices - so if you have ever seen a ‘FDA approved’ LED light therapy mask, this is a misnomer.

FDA approval is required for Class III devices before they are introduced onto the market. Manufacturers are required to establish to a satisfactory and science-backed standard that there is ‘reasonable assurance the devices are safe and effective for their intended use.’

What is FDA-Clearance?

FDA clearance is required for moderate risk medical devices (Class II), this includes powered 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 legally marketed predicate device that does not require premarket approval.’ In simple terms, a similar device already exists on the market. The manufacturer uses the 510(k) process to review class II products.

So as we said earlier - an LED light therapy device cannot be ‘FDA-approved’ as it does not meet the risk category associated with this regulatory requirement. So LED light therapy devices are considered ‘FDA-cleared’ if they have passed this process. It is important not to think of FDA-clearance as an ‘inferior’ or ‘less safe’ regulatory procedure, it's simply a different review process based on the specific risk presented by the device.

What is FDA-Registration?

FDA-registration simply means that a company has registered with the FDA and provided information on their company and have listed the product on the FDA website. In essence, don’t pay too much attention to this as a consumer.

Should LED Masks be FDA-Cleared?

When trying to decide what LED face mask you should invest in the questions are endless. How do I know my LED face mask is FDA approved? Which LED light brands are FDA approved? Or importantly, should LED masks be FDA-approved?

As we stated, but we will state again as it is significant, LED light therapy devices cannot be FDA-approved - it is definitely a brand red flag if they are making these claims, whether intentional or not, it could indicate a lack of knowledge on the topic.

When it comes to FDA-clearance however, the color of the LED plays a role in whether the device has been the subject of FDA-clearance. Red, blue and infrared light therapy have been cleared by the FDA - however the other LED colors on the visible light spectrum have not.

This is why, as you may notice, devices containing green, yellow, purple, cyan, or white light do not have FDA-clearance. There are several studies that attest to their effectiveness, however they just have not to date been subject to the clearance process. With these colors, the important thing is to look for third-party safety verification such as the CE mark. This ensures the product is safe for home use.

Is Red Light Therapy FDA-Approved?

No, but it is FDA-cleared. If your device has red light only, or any combination of red, blue and infrared light, is capable of being approved by the FDA, and therefore really should be. FDA-clearance for blue, red and infrared devices ensures they meet the highest standards of safety and efficacy and are cleared for home use. The FDA defines red LED light therapy as ‘light based over the counter wrinkle reduction’ that ‘uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles’

Blue light therapy is defined by the FDA as ‘over-the-counter powered light based laser for acne’. These descriptions authenticate claims made by LED light therapy mask retailers on the benefits of red and blue LED for anti-aging and acne respectively.

Why are Some LED Light Therapy Devices FDA-Cleared and Others Are Not?

Red, blue and infrared light therapy devices are capable of being FDA-cleared - this is because the FDA regulates any ‘medical claims’ made by device manufacturers. Blue and red and infrared and have been used as medical treatments for several decades. Infrared, blue and red light therapy claim benefits that can technically be described as medical benefits.

Why is my 7 Color LED Light Therapy Mask Not FDA-Cleared?

While many studies have shown the effectiveness of yellow, green, purple, white and cyan light therapy in providing aesthetic benefits, they have not been used in medical therapies to the same extent as red, blue and infrared. They therefore have not been the subject of FDA-clearance or approval procedures to date. In fact, any LED device with treatment colors outside red and blue will not be FDA-cleared.

The FDA’s clearance and approval procedures are a constantly changing process, with some devices moving from class II to class III and devices being newly introduced to the approval and clearance procedures, so it is not outside the scope of possibility that the other visible light therapies will one day require FDA-clearance.

Devices

LightAura Flex | LED Face Mask

Red and blue silicone LED light therapy mask for smoothing fine lines and eliminating acne

View product

The Takeaway: Are At-Home LED Light Therapy Devices at Home Safe and Effective?

FDA-clearance is important for infrared, blue, and red LED light therapy face masks. Clearance attests to their safety and efficacy in full skin rejuvenation including, managing acne, anti aging and healing and regenerative processes, and other claims.

Because purple, green, yellow, cyan and white light LED light therapy devices have not been used in medical treatment to the same extent as red, blue and infrared, they have not been the subject of FDA-clearance procedures to date, this position of course, could change in the future.

When choosing the perfect LED light therapy mask for you, FDA-clearance could be a priority, and there are plenty of great options meeting this standard , however if you want to treat a broader range of skin concerns, a 7 color LED light face mask may be the right choice for you.

Knowledge is power when it comes to investing in a LED light therapy mask so be sure to check out some of our other blogs to help kick the decision paralysis and start your skin journey with LED.

Full Range of FDA-cleared project E Beauty LED Devices

LightAura Flex | LED Face Mask
Lumamask Pro | LED Light Therapy Face Mask
LumaGlow Red & Blue | LED Light Therapy Wand
LumaBlue | LED Light Therapy Cleansing Brush
LumaGlow Blue | Anti-Acne LED Light Therapy Wand
LumaGlow | Red LED Light Therapy

 written by Charlotte Rycroft