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Is Red Light Therapy FDA Approved?
John Tsenekos
March 14, 2025
8 MINS READ
Red Light Therapy is a non-invasive skincare treatment that uses specific wavelengths of light to deliver targeted anti-aging results to the skin. As good as this sounds, there are a ton of products and devices that promise anti-aging results, so how do you know Light Therapy devices are effective and safe to use? This is where regulations come in, and in the United States, the US Food and Drug Administration (FDA) is the agency in charge of devices like these.
Let's go over what you need to know about Red Light Therapy and the FDA, including a common misconception about FDA approval when it comes to skincare.
What is FDA Approved?
FDA approval is a specific designation granted by the U.S. Food and Drug Administration after a thorough evaluation process that confirms a product's safety and effectiveness for its intended use. The FDA approval process is comprehensive and rigorous, primarily applied to:
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New drugs and medications
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Biological products (like vaccines, blood products, and gene therapies)
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High-risk (Class III) medical devices that support or sustain human life, prevent impairment of health, or present potential unreasonable risk of illness or injury
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The approval process typically involves several phases of clinical trials to demonstrate that the benefits of the product outweigh its known risks. Manufacturers must provide substantial scientific evidence through laboratory, animal, and human clinical testing to prove safety and efficacy before receiving approval.
For drugs and biologics, this process can take years and involves detailed review of all test results. For high-risk medical devices, manufacturers must submit a Premarket Approval application (PMA) with comprehensive scientific evidence demonstrating safety and effectiveness.
It's important to understand that FDA approval is not required for all products. The FDA uses a risk-based approach to regulation, with different pathways for different product categories based on their potential risk to consumers.
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What's the Difference Between FDA Approved and FDA Cleared?
FDA Approval refers to a comprehensive evaluation process conducted by the U.S. Food and Drug Administration (FDA) for drugs, biologics, and certain high-risk medical devices (Class III devices). This process requires extensive scientific evidence from clinical trials to demonstrate that the product is safe and effective for its intended use. FDA approval signifies that the product has met stringent standards and is deemed safe for public consumption or use.
FDA Clearance, on the other hand, applies to Class II medical devices, including those used in Red Light Therapy. Devices seeking FDA clearance must demonstrate substantial equivalence to a legally marketed device that has already been approved or cleared. This means the new device is at least as safe and effective as the existing one. The clearance process does not typically require extensive clinical trials but instead focuses on safety and performance standards.
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The key difference between the two lies in the level of regulatory review and evidence required. FDA approval involves a more in-depth evaluation with a higher burden of proof, while FDA clearance primarily relies on demonstrating substantial equivalence to an existing device. Both processes ensure that products meet safety standards, but FDA approval is typically reserved for products with a higher risk profile.
Is Red Light Therapy FDA Approved?
Red Light Therapy itself is not FDA approved as a treatment, since the approval process is primarily reserved for drugs, biologics, and certain high-risk medical devices. However, Red Light Therapy devices can be FDA cleared, meaning they have been evaluated and determined to be substantially equivalent to existing, legally marketed devices.
The FDA clearance process for Red Light Therapy devices involves a thorough regulatory review to ensure they meet specific safety and performance standards. This clearance confirms that the devices are safe for use.
Best FDA Cleared Red Light Therapy Devices
Explore the top FDA-cleared Red Light Therapy devices that can elevate your skincare routine with their advanced technology and proven benefits:
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Red Light Therapy Eye Mask
This innovative eye mask combines four powerful light therapies: Red Light, Deep Red Light, Near-Infrared Light, and Amber Light. Together, they work to visibly minimize signs of skin aging in the delicate eye area, including 11s, crow's feet, dark circles, and puffiness. Designed for comfort and ease at just three minutes per treatment session, this mask is a non-invasive solution to refresh the appearance of your eye area, making it a perfect addition to your skincare regimen.
Wrinkle Retreat Light Therapy Face Mask
The Wrinkle Retreat Face Mask utilizes Red Light and Near-Infrared Light Therapies to target visible signs of skin aging and promote a glowing and healthy-looking complexion. The mask is designed for regular use and needs just ten minutes to deliver a full-face treatment!
Bye Acne 3-Minute Pimple Spot Treatment Device
This award-winning device combines Red and Blue Light Therapies to target mild-to-moderate acne and redness. The portable and non-invasive Bye Acne device delivers a quick 3-minute treatment per spot, helping to reduce acne-causing bacteria and the inflammation it causes.
How Else Can I Know Red Light Therapy Works?
Red Light Therapy's effectiveness is supported by both scientific studies and real-life testimonials. By delivering low-level wavelengths of Red Light, this safe and non-invasive therapy promotes skin that looks radiant and glowing without downtime or side effects for most individuals.
Other forms of Light Therapy have also proved effective, which is why you'll see we typically include more than one form of Light Therapy in each of our devices. Near-Infrared Light visibly rejuvenates the complexion, while Deep Red Light visibly boosts skin's glow and smooths the look of fine lines. Amber Light helps improve the look of unevenness and puffiness.
You can explore more about the science behind Red Light Therapy on our Science page.
The science behind Red Light Therapy is complemented by the experiences of users who have witnessed remarkable transformations.
For instance, the Solawave 4-in-1 Skincare Wand combines Red Light Therapy with Galvanic Current, Therapeutic Warmth, and Facial Massage to visibly reduce fine lines, dark circles, blemishes, and puffiness in just two weeks. Users like Samantha, who noticed a significant visible reduction in the wrinkle between her eyebrows, and Krisanne, who experienced tighter- and brighter-looking skin, attest to the therapy's impact.
Moreover, the Bye Acne 3-Minute Pimple Spot Treatment Blue Light Therapy device utilizes both Red and Blue Light Therapies to target acne and inflammation effectively. Users like Sarah and Ingrid have reported clearer skin and reduced breakouts after incorporating this device into their routines.
You can see these transformations on our Before & After Results page.
These testimonials, combined with the scientific foundation of Red Light Therapy, provide compelling evidence of its potential to enhance your skincare routine, offering a professional-grade solution for achieving healthier-looking, glowing skin.
Conclusion
In exploring the world of Red Light Therapy, you've discovered its potential to enhance your skincare routine by targeting visible signs of skin aging and promoting a radiant-looking complexion. Plus, with our FDA-cleared Light Therapy devices, you can confidently incorporate this non-invasive treatment into your regimen, knowing it meets safety and performance standards. The combination of scientific backing and real-life testimonials underscores the effectiveness of Red Light Therapy in achieving healthier-looking, glowing skin.
If you're ready to get started with your own at-home Red Light Therapy device, take our device quiz here to get matched with the tool that aligns with your personal skincare goals!
Frequently Asked Questions
Q. Is Solawave FDA approved?
Solawave devices are not "FDA approved" but rather "FDA cleared," which is the appropriate regulatory pathway for these types of medical devices. At-home devices like those from Solawave don't require the same "FDA approval" process that drugs and high-risk medical devices do. Instead, they undergo FDA clearance, which involves demonstrating that they are substantially equivalent to existing legally marketed devices in terms of safety and effectiveness.
All Solawave Red Light Therapy products are FDA cleared for light therapy, meaning they have been evaluated by the FDA and determined to meet safety and performance standards. This clearance provides assurance that the devices are safe for their intended use when used according to directions. The Solawave Radiant Renewal 4-in-1 Skincare Wand, Wrinkle Retreat Light Therapy Face Mask, Eye Recovery Pro Mask, and other products in their lineup carry this important FDA clearance designation.
Q. What does FDA registration mean?
FDA registration is a basic administrative requirement that is distinct from both FDA approval and FDA clearance. When a company registers with the FDA, they are simply listing their establishment and devices with the agency—it does not mean the FDA has evaluated or validated their products for safety or effectiveness.
Registration is mandatory for manufacturers, distributors, and importers of medical devices and must be renewed annually. It provides the FDA with information about who is making, importing, or distributing devices in the U.S. market, but it involves no testing or review of the actual products.
This is an important distinction for consumers to understand: seeing that a product is "FDA registered" only indicates that the company has completed this basic administrative step. It does not mean the product has undergone any evaluation for safety or efficacy, unlike FDA-cleared devices which have been assessed for substantial equivalence to legally marketed devices.
When shopping for Red Light Therapy devices, look for "FDA-cleared" status rather than just "FDA-registered" to ensure the product has actually been reviewed for safety and performance standards. All Solawave devices go beyond simple registration and have received FDA clearance, giving you confidence in their safety and effectiveness.
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