A trend in light medicine: Products getting called “medical-grade red light therapy devices.”
Is there a real distinction? Do some red light devices meet medical-grade standards?
Here’s a short answer:
When used to describe red light therapy devices, “medical-grade” implies a higher standard for safety and efficacy. However, the term can be misleading.
For one, there isn’t a standard definition. Medical-grade may be used to describe:
Medical-grade certified components
FDA status
Quality of LED light
Device’s irradiance & output
Commercial vs. consumer devices
This can cause a lot of confusion for consumers, and most want to know if a “medical-grade” is device better?
Here’s what we recommend:
If you’re looking for an effective red light therapy device (to treat a specific condition), focus on these measures: Irradiance, LED quality, and wavelength. Plus, in addition to output, you’ll also want to consider proper use and dosage.
Ultimately, when it comes to medical-grade red light therapy, dosage (precisely measuring it) is the most important factor to experience therapeutic benefits.
Medical-Grade Red Light Therapy: What Is It?
The term “medical-grade” – as it refers to red light therapy – isn’t well-defined. Often, it has a different meaning for manufacturers and consumers.
For consumers, “medical-grade” implies the device is more effective and may have undergone clinical tests to verify efficacy. However, that’s usually not true.
Instead, for manufacturers, labeling a red light device “medical-grade” may just mean:
Component Safety
The device meets specific IEC standards for electrical medical device safety. For example, the IEC maintains safety standards for electrical medical devices.
Thus, technically, a device that meets these standards could be called a medical-grade red light therapy device, because it uses medical-grade components.
Medical Wavelengths
The device delivers specific medically recognized wavelengths of red light. This includes visible red wavelengths (about 630nm to 670nm) and near-infrared wavelengths (810nm to 850nm).
Many research studies have found that these wavelengths fall in the therapeutic window, and researchers believe these wavelengths are most effective for photobiomodulation treatments. The best red light therapy beds and devices provide a wide range of medically relevant wavelengths.
LED Quality
There isn’t a universally recognized grading system for LEDs like there is for diamonds or lumber. Therefore, the terms “medical grade” or “commercial grade” do not have strict definitions.
However, there are indicators that are well-established for LEDs, and these can be used to assess quality:
Wavelength: As mentioned above, tight control over the specific wavelength emitted is crucial for red light therapy.
Luminous efficacy and lumens per watt: These metrics indicate how efficiently the LED converts electricity into light output.
Lifetime: This refers to the expected lifespan of the LED before its light output degrades significantly.
Failure rates: Low failure rates indicate higher quality and reliability.
Rigorous Approval
Don’t be fooled by the term “medical-grade” when it comes to red light therapy devices. While it might sound like the FDA has rigorously tested and approved the device, that’s often not the case.
FDA approval is a tough hurdle to clear, requiring in-depth studies and clinical trials to prove a device is effective for specific health conditions. In reality, most red light therapy devices are FDA Cleared or FDA Registered. Clearance ensures the device meets safety standards but doesn’t guarantee its effectiveness for specific health conditions.
Medical-Grade Devices: Examine Their Output
If you’re looking for a red light therapy device with a specific therapeutic outcome in mind, focusing on “medical-grade” devices might not be the most helpful strategy. Instead, prioritize these features:
Wavelength: Different wavelengths of light penetrate tissues at varying depths and may have specific benefits. Look for devices that emit wavelengths with proven potential for your desired outcome (e.g., 630-660nm for skin treatments or 810-850nm for muscle pain).
Dosage: A true medical-grade red light device allows you to fine-tune the dosage (measured in Joules per square centimeter). The right dosage is essential for achieving a therapeutic effect. Too little light may not trigger a cellular response, while too much light can have negative consequences. Factors that can influence dosage include treatment time, irradiance, and the user’s distance from the device.
Irradiance: A quality LED light therapy devices should provide specific outputs of light. This intensity can be varied based on the user’s distance to the light source, or adjustable in the device’s setting. A higher irradiance (34 mW/cm2 to 100 mW/cm2 in our Photobiomodulation Chamber, for example) can provide the desired dose in a shorter amount of time.
Benefits of Medical-Grade Red Light Therapy Devices
Devices that are used for physical therapy, post-surgery recovery, pain management, or other medical applications, typically contain a more robust feature set and output. Therefore, if a device meets medically significant output, it may offer improved outcomes.
These potential benefits include:
Deeper Tissue Penetration: Medical-grade devices may deliver higher irradiance, which is the light’s power density. This translates to deeper penetration into tissues, potentially leading to more significant therapeutic effects. This is important for treating issues like knee or muscle pain.
Treating Larger Areas: Medical-grade devices frequently have larger treatment areas compared to consumer-grade devices. This enables them to cover broader zones during treatment sessions, saving time and potentially improving treatment efficiency.
Advanced Treatment Options: Some medical-grade devices boast advanced treatment modes. These might include continuous light emission or pulsing patterns, offering healthcare professionals more treatment options to tailor therapy to individual needs.
Beyond these features, proper use is very important for medical red light therapy.
For example, a user’s distance from the device can greatly affect dosage. The difference between 6 inches and 12 inches away, for example, could be the difference between medically beneficial or not.
Therefore, if your aim is to provide a medical benefit, consult with a professional or a red light therapy expert. And if you’re a clinician, read the latest dosage research, to help optimize output for your clients.
Consumer vs Commercial Red Light Devices: Finding the Right Fit
Sometimes, “medical-grade” gets used interchangeably with commercial-grade. However, some commercial devices and at-home devices can be considered “medical-grade”, due to their output, quality and the wavelengths they provide.
For example, our at-home red light therapy device – the Abdomen PBM Irradiator – provides a potentially beneficial dose of red light (780-940nm at 30-70 mW/cm2). Plus, it offers wavelength adjustability and programmable pulsing modes to further tailor the output.
However, there are some differences between at-home and commercial RLT devices. They include:
Power – Many cheap RLT devices have lower light output. This often translates to longer treatment times. Always assess the quality to maximize health benefits.
Wavelengths – Most devices built for at-home use are designed for a single application, and therefore have a limited wavelength band. For example, many skincare devices offer just 1 or 2 visible red wavelengths.
Build Quality – At-home devices are not designed for frequent commercial use. Commercial devices typically have sturdier components and on-demand support.
Adjustability – Commercial devices typically offer advanced features like timers, adjustable settings, pulsing, and pre-programmed treatment protocols.
Cost – Commercial-grade devices may be more expensive due to their more robust builds, higher power ratings, and advanced features.
In other words, always research the product. Typically, a true “medical-grade” product that delivers a beneficial dose, which you can tailor to your specific condition, costs more.
Are Hue Light USA Devices Medical-Grade?
Hue Light USA offers a variety of state-of-the-art photobiomodulation, e.g. red light therapy, devices. Both our commercial and at-home devices have been designed to deliver a potentially therapeutic dose of red light.
For example, all our devices are equipped with red and near-infrared wavelengths and pulsing and continuous light modes. They also offer ample irradiance for deeper penetration (when treating muscle pain) and this may also reduce average treatment times.
Our devices include:
Breast PBM Irradiator – Ideal for targeting breast pain and discomfort; it may be beneficial for breast cancer-related pain.
Abdomen PBM Irradiator – Supports gut health and promotes a healthy microbiome, as well as targeted treatments for other areas.
However, the term “medical-grade” can be misleading. When choosing a device, focus on factors like wavelength, irradiance, dosage, and quality. These factors are the most important for offering therapeutic benefits from RLT.
Consulting a healthcare professional can be beneficial, as well, especially if you aim to treat a specific medical condition. Finally, if a manufacturer makes claims of efficacy, always research their trials and methods.
FAQs
At-home devices can be effective, but they may have lower power outputs and fewer features compared to commercial-grade devices. Look for devices with adjustable settings and wavelengths appropriate for your desired treatment.
No. The term "medical-grade" isn't strictly regulated. However, it may signify the device has undergone more rigorous testing and potentially demonstrates some level of efficacy for specific conditions. Research a company’s medical claims before purchasing the device.
Not necessarily. Some medical-grade devices are designed for at-home use, but with proper guidance. However, if you have a specific medical condition you're targeting, consulting a healthcare professional familiar with red light therapy is recommended. They can help determine the appropriate dosage and treatment plan for your needs.
Medical-grade devices tend to be more expensive than at-home models due to their higher power outputs, advanced features, and improved build quality designed for frequent use.
Disclaimer: The information provided here is for educational and informational purposes only and is not intended as a direct reference to any products offered by Hue Light USA or any specific brand. We do not claim that our products can achieve the effects or benefits discussed in this content. This information should not be interpreted as medical advice or as an endorsement of any specific product or treatment. We encourage readers to conduct their own research and consult with a qualified healthcare professional before making any decisions regarding their health or wellness regimen.
