As the market for red light therapy continues to expand, it’s crucial to understand the importance of using devices that adhere to proper manufacturing standards—specifically, those that meet FDA registration requirements. Unfortunately, not all equipment on the market is manufactured following these stringent guidelines, leading to potential risks for both manufacturers and service providers.

The Necessity of FDA Registration

The FDA (Food and Drug Administration) plays a critical role in ensuring that medical devices, including red light therapy equipment, are safe and effective for consumer use. FDA registration is not merely a formality; it is a rigorous process that requires manufacturers to demonstrate compliance with a comprehensive set of standards. These standards cover everything from the design and manufacturing processes to post-market surveillance.

However, not all manufacturers in the red light therapy space are FDA-registered or properly registered. This non-compliance can lead to significant consequences, including the possibility of being shut down by regulatory authorities.

Risks of Non-Compliance

Manufacturers that fail to adhere to FDA registration standards are operating in a risky gray area. If discovered, these companies could face serious legal consequences, including being forced to cease operations. Even more severe, they may be required to recall all non-compliant equipment from the market, leading to financial losses and damage to their brand’s reputation.

But the risks don’t stop with the manufacturers. Businesses and practitioners using non-compliant red light therapy equipment are also at risk of falling under FDA scrutiny. If a business is found to be using equipment that does not meet FDA standards, they could face penalties, including fines, and may be required to cease offering red light therapy services until compliant equipment is obtained. This not only disrupts operations but can also harm the business’s reputation among clients.

Protecting Your Business and Clients

To safeguard against these risks, it is essential for businesses offering red light therapy to ensure that all equipment used is sourced from FDA-registered manufacturers. This includes verifying the manufacturer’s registration status and ensuring that the equipment has been properly registered with the FDA.

As the demand for red light therapy continues to grow, so too does the responsibility to ensure that the equipment used is safe, effective, and compliant with FDA standards. By prioritizing FDA-registered equipment, businesses can protect themselves from legal risks and provide their clients with the highest standard of care. In a market where not all manufacturers adhere to these crucial regulations, due diligence is not just recommended—it is essential.

SmartSun Therapy: FDA Registered

 The SmartSun® Therapy Device (OvationULT) is registered under FDA 21 CFR 890.5500 REN#3010627475.

In 2016, the FDA determined that certain general wellness products do NOT require FDA Clearance or 510(k) Clearance. Instead, these devices are simply “registered” with the FDA as General Wellness Products. The Center for Devices and Radiological Health (CDRH) defines general wellness products as products that meet the following two factors: (1) intended for only general wellness use and (2) present a low risk to the safety of users and other persons. The new policy states that:

“CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).”

For more information, visit SmartSunTherapy.com or call 800-988-8712.