Is Red Light Therapy FDA Approved?: Know the Answer


When it comes to choosing the ideal red light therapy device, the first thing you need to pick is whether the devices are FDA-approved. 

Now, are all red light therapy devices FDA-approved? No, not all are! To get FDA approval, there are certain criteria that the device manufacturers must comply with. However, PlatinumLED devices are FDA-approved and are also considered one of the best in the industry. 

So, here in this blog, we’ll let you know all the criteria that an RLT device must go through to get FDA approval. Binge on till the end of the blog.

FDA Approval Criteria List for Red Light Therapy Devices

The FDA’s approval process for red light therapy includes several important criteria. Here in this section, we’ve listed out all the major points that red light therapy devices need to follow to be FDA-approved. 

  • Safety: The FDA makes sure of the safety of the device, looking at factors like the materials used, the potential risk of tissue damage, and any other risks associated with its use. For red light therapy, safety is a “must to look at” concern as it is being used directly on the body. And most importantly, the tissues and muscles.

  • Efficacy: In addition to the overall safety, the FDA assesses the device’s effectiveness. For red light therapy, it means looking at whether the device delivers the intended therapeutic benefits, like pain relief, improved circulation, or skin rejuvenation. Plus, the clinical studies and data are crucial too, this ensures the device is eligible for use and doesn’t have any adverse effects on the user.
  • Quality Control: The overall manufacturing process and quality control measures are also monitored for these devices to get FDA approval. 

This ensures that each device manufactured is consistent in its performance and meets the specifications outlined in the FDA approval. 

That’s not all; quality control is vital for red light therapy devices to ensure that the emitted wavelengths are accurate and consistent for each treatment.

  • Clinical Data: Before approval of a red light therapy device, manufacturers must submit clinical data supporting the device’s claims. 

This data comes from studies and trials that showcase the device’s effectiveness for its “actual” use. For red light therapy, this might include data on skin improvements, pain reduction, or any other claimed benefits.

  • Labeling and Instructions: FDA-approved devices must come with clear labeling and instructions for the user. This includes info on “how to” operate the device safely, how long treatments should last, and the potential risks the device may come up with. Clear labeling helps users to use the device safely and without any consequences. 

Reasons Why PlatinumLED Light Therapy Devices Have Been FDA Approved

Here in this section, we’ll let you know the possible reasons why RLT devices are FDA-approved and from here PlatinumLED stands out at the top of the list.


Red light therapy devices have received FDA approval because it has clearly shown its safety profile. Before a device is approved, it undergoes several tests to ensure it doesn’t cause harm when used as directed. 

This includes assessments of the wavelengths used, their penetration depth, and their impact on human tissues. Here PlatinumLED devices have met safety standards set by the FDA, providing users with confidence.


FDA approval also indicates that red light therapy has shown efficacy for certain conditions. For instance, it has been approved for the temporary relief of minor muscle and joint pain, along with the promotion of the relaxation of muscles and increasing blood circulation. 

PlatinumLED’s clinical trials and studies have provided evidence supporting all their claims, showing that their rlt devices can have tangible benefits when used correctly.

Wavelengths Regulation

The FDA approval process ensures that red light therapy devices meet specific criteria about the wavelengths being released. Different light wavelengths have different effects on your body, and the FDA approval shows that the device emits wavelengths within a range that is safe and effective for the user. 

Even here PlatinumLED devices excelled and delivered the perfect wavelength range that would benefit the user. 

Quality Check

According to the FDA approval criteria quality check is a must. Meaning that approved red light therapy devices are manufactured under strict guidelines to ensure consistency and reliability. 

Here consumers can trust PlatinumLED as their “ultimate” RLT device, as the FDA has also cleared this company’s devices as one of the best according to quality assurance.  

Transparent Labeling and Instructions

Transparency is a must when you want your medical device to be approved by the FDA, and PlatinumLED did quite well here. Its device instructions, including the BIOMAX series, come with a clear and ideal instructions manual that would help the users know what they should do. 

Clinically Proven Benefits

To receive FDA approval, red light therapy devices must provide evidence of their benefits through clinical studies. Even after thorough research on the red light therapy of PlatinumLED, they still showed all the necessary trial evidence that supports their claims. And these were even cross-examined by scientists and researchers. After all the trials and errors, PlatinumLED cleared this criteria list of the FDA.

Clearance for Specific Conditions

In certain cases, red light therapy devices receive FDA clearance for specific conditions. For instance, devices may be cleared for the treatment of acne or the improvement of skin texture. 

And the devices only get the clearance if they serve these mentioned purposes. PlatinumLED even got its clearance for aiding patients to achieve proper acne treatment along with proper skin texture. 

Bottom Line

It’s a must that you only go for those devices that are approved by the FDA. This is because it ensures your safety along with the effectiveness that you need for optimum results. Here, PlatinumLED stands out at the top, and you can surely keep its devices at the top since they’re proven to serve the users with the utmost best!