Red Light Scams Are Real: How to Verify an FDA Registered Device

The red light therapy market is experiencing incredible growth, but with that popularity comes a flood of new devices—and not all are created equal. For business owners looking to invest in this technology, it can be difficult to sort through the hype and verify the legitimacy of a company's claims.

One of the most common and misleading areas is a device's status with the U.S. Food and Drug Administration (FDA). Understanding how to check this yourself is the single most important step in protecting your business and ensuring you're investing in a safe, credible product.

This guide will walk you through exactly how to do it.

Step 1: Know the Terminology: Registered vs. Cleared

First, it’s important to understand the language. Companies sometimes use terms like "FDA Approved" incorrectly, which can be a red flag. For devices like ours, there are typically two relevant classifications:

• FDA Registered: This means the company and its devices are listed in the FDA's database. Manufacturers of Class I and Class II over-the-counter devices are required to register their establishments and list their devices with the FDA annually. Our therapy beds, for example, are over-the-counter devices intended to provide topical heating for temporary pain relief and increased circulation.
  
  
• FDA Cleared (510(k)): This is a more intensive premarket process where a company demonstrates that their device is "substantially equivalent" to another legally marketed device. This is often required for devices intended to make specific medical claims.

A legitimate company should be transparent about which classification applies to their specific device.

Step 2: Use the FDA's Public Database

You don't have to take a company's word for it—you can check the FDA's official database yourself.

1. Navigate to the FDA Establishment Registration & Device Listing database.
2. You can search by the Establishment or Trade Name (the company's name).
3. Once you find the company, you can view its profile, including its registration status and a list of the devices it has officially listed.

This simple search can instantly tell you if the company you're considering is in compliance with FDA registration requirements.

Step 3: Spot Common Red Flags

As you research, keep an eye out for these common warning signs:

• Vague or Incorrect Language: As mentioned, be wary of the term "FDA Approved." For most therapy beds, "FDA Registered" or "FDA Cleared" is the more accurate terminology. Misuse of these terms may signal a lack of expertise or an attempt to mislead.
  
  
• Miracle Claims: Responsible companies speak about their products with precise, compliant language. Be cautious of any device that claims to cure serious diseases or offers guaranteed, permanent results for complex conditions. The intended use for our devices, for instance, focuses on temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasms, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
  
  
• Lack of Transparency: If a company is unwilling to discuss its regulatory status or provide you with a registration number, consider it a significant red flag.
  

Investing in a red light therapy device is a major decision. By equipping yourself with this knowledge, you can confidently navigate the market, cut through the noise, and choose a device from a partner company that prioritizes safety, transparency, and results.