FDA Approved Red Light Therapy Devices for Pain in 2024
Are you looking for an FDA-approved red light therapy device? Here are two devices you should know more about.
Interestingly, red light therapy devices don’t require pre-market approval due to their low risk, but some may be “cleared” or “registered” by the FDA after undergoing a thorough review process known as 510(k). Learn more about “FDA Approval” below.
NovaaLab Extra Laser
NovaaLab Healing Pad
Best FDA Cleared Red Light Therapy for Pain
Extra Strength Laser
Class II FDA Registered Device
Product | NovaaLab Extra Laser |
Excellent for | Arthritis, Muscle Aches, Neuropathy, Tendonitis |
Price | $399 |
Sale Price | $299 |
Extra Strength Laser Overview
When asked for a fast pain relief device that isn’t as pricey as the Visum, I recommend the NovaaLab Extra Strength Laser.
I love the Extra’s targeted light, which has the power to provide fast relief.
The Novaalab Extra Laser Pain Relief is a portable device used at home or on the go.
The rechargeable battery lasts a week on one charge, which is much more convenient than lesser competitors.
The red and infrared laser light penetrates arthritis, tendonitis, and inflammation.
The NovaaLab Extra is affordable compared to other pain relief treatments.
This device uses red light therapy to provide a natural and noninvasive way to relieve joint pain, muscle tension, and other types of discomfort.
Key Benefits
Price
The Laser Extra is $399 on sale for $299.
Pros
Cons
Pros and Cons
Our Take
If you’re dreaming of getting the Visum Light but want a much cheaper option, the Extra Laser is great. The treatment times are fast, and you can expect results anywhere from right away to within a week of daily use.
The Extra Laser is comfortable and easy to use. It’s not hands-free, a feature multi-taskers often want. However, the treatment time is only 5 minutes.
NovaaLab has a generous return policy of 60 days.
Product | NovaaLab Extra Laser |
Excellent for | Arthritis, Muscle Aches, Neuropathy, Tendonitis |
Price | $399.90 |
Sale Price | $299.90 |
Light Pad
Class II FDA Registered Device
Product | Novaa Light Pad |
Excellent for | Arthritis, Muscle Aches, Neuropathy, Tendonitis |
Price | $299 |
Light Pad Overview
The Novaa Deep Healing Pad is a Class II FDA-registered device. It is a highly regarded red light therapy device for pain relief.
This quality, budget pad is best for back and knee pain. It’s also the most popular red light therapy device on this website. It offers a large surface area for optimal light exposure and covers the knee, stomach, or lower back.
Key Benefits
Price
NovaaLab runs frequent sales, you should be able to pick up the Pad for $299.90.
Pros and Cons
Pros
Cons
Our Take
The Light Pad is an effective, portable, affordable red light therapy pad for pain relief. Athletes buy it for daily use. Initial results might take a few weeks as it’s not as strong as the Extra Laser or Visum Light. Get a cell phone USB battery to make the Light pad portable. NovaaLab has a generous 60-day return policy.
Product | NovaaLab Light Pad |
Excellent for | Arthritis, Muscle Aches, Neuropathy, Tendonitis |
Price | $299 |
What is FDA Approval (Clearance) for Red Light Therapy Devices)?
In the U.S., the FDA regulates the safety and effectiveness of medical devices.
The FDA oversees approximately 175,000 medical devices and receives over 22,000 premarket submissions for review each year.
Among these medical devices are red light therapy devices, which have gained popularity recently for their potential health benefits.
Defining “FDA Cleared,” “FDA Registered,” and “FDA Approved”
It’s essential to understand the terminology surrounding the FDA’s evaluation process.
Red light therapy devices are not FDA-Approved. They are FDA cleared for marketing as Class II medical devices.
What Does “FDA-Cleared” Mean?
“FDA-Cleared” refers to medical devices that have been evaluated by the FDA and cleared for marketing because they are substantially equivalent to a legally marketed device.
FDA-cleared is also referred to by these terms:
- FDA-cleared for marketing
- 510(k) clearance
FDA-clearance (510(k) clearance) is for low to moderate risk medical devices that are substantially equivalent to an already legally marketed device. Requires comparing to predicate device but no clinical trials.
FDA Clearance Classes
The FDA assigns medical devices into three regulatory classes based on the level of control necessary to assure safety and effectiveness. Red light therapy devices are FDA Class II.
Device Class | Examples |
---|---|
Class I | Bandages, dental floss, tongue depressors |
Class II | Red light therapy devices, pregnancy test kits, powered wheelchairs, surgical drapes |
Class III | Implantable pacemakers, cardiac stents, breast implants |
FDA Clearance Class I
The lowest risk devices such as bandages are Class I devices. Class I devices are subject to “general controls” to keep the public safe.
FDA Clearance Class II
Moderate risk devices such as powered wheelchairs are Class II devices. Class II devices are subject to “general controls” and “special controls.” Most 510(k)-cleared devices are Class II. Class II devices might or might not require submission of clinical data.
FDA Clearance Class III
Class III devices are the highest risk devices like pacemakers. General controls alone cannot provide reasonable assurance of safety and effectiveness. Class III devices require premarket approval (PMA) to ensure safety and effectiveness.
What Does FDA-Registered Mean?
“FDA-Registered” means that facilities that manufacture, process, pack, or hold food, drugs, or medical devices have registered their facility with the FDA and provided a list of products made at that facility. Registration does not denote approval of the products made there. It is mainly for FDA traceability.
What does FDA-Approved Mean?
“FDA-Approved” means the FDA has reviewed clinical trial data and determined that a medical device, drug, or biologic is safe and effective for its intended use. FDA approval is required before marketing most medical products in the US.
Conclusion
Red light therapy devices are not FDA-Approved. They are FDA cleared for marketing as Class II medical devices.
Two excellent examples of FDA-cleared red light therapy devices are the Novaa Extra Laser and the Novaa Light Pad.