What Medical-Grade Red Light Therapy Really Means

As red light therapy has grown in popularity, the term “medical-grade” has become increasingly common. It has also become one of the most misunderstood. Many products use the term loosely, often tying it to light output, isolated test results, or certification language that does not reflect whether a device has been engineered and evaluated to medical safety standards.

Understanding what medical-grade truly means requires looking beyond surface-level metrics and focusing on how a device is designed, manufactured, tested, and verified as a complete system.

This article explains what medical-grade means in the context of red light therapy, what it does not mean, and why independent safety certification matters.

What “Medical-Grade” Actually Means

Medical-grade does not describe a single feature or measurement. It refers to how a device is engineered, manufactured, and independently evaluated against recognized medical electrical equipment safety and performance standards.

These standards are used globally to assess whether devices are safe and reliable for use around people in both professional and home healthcare environments. They evaluate the complete device system, not just light output or individual components.

At a high level, medical-grade evaluation considers:

• Electrical safety and protection against shock
  

• Insulation, grounding, and fault tolerance
  

• Electromagnetic compatibility
  

• Usability and human interaction
  

• Photobiological exposure limits
  

• Reliability under normal and abnormal operating conditions
  

A product that meets these requirements has been evaluated for real-world use, not just laboratory performance.

The Role of Third-Party Testing and Certification

Independent third-party testing is a defining requirement of medical-grade devices. This testing must be performed by a Nationally Recognized Test Laboratory (NRTL) and conducted against established medical electrical equipment safety standards.

Joovv devices are independently tested and certified by Intertek. This process includes medical electrical equipment safety and performance standards, including IEC 60601-1 for basic safety and essential performance, IEC 60601-1-6 for usability, IEC 60601-2-57 for photobiological safety, and IEC 60601-1-11 for medical devices intended for use in home healthcare environments.

Most importantly, IEC 60601-1-11 evaluates whether a device can be used safely in uncontrolled, non-clinical home environments. This includes additional requirements for electrical safety, fault conditions, usability, and risk mitigation specific to home use.

Certification scope and applicability can be independently validated through Intertek or other NRTL organizations and are not based on self-reported or selective testing results. In addition almost all electrical medical equipment or components include a CB certificate issued by the IECEE. This is an international document that provides global verification and conformance to safety standards.

A detailed breakdown of Joovv’s testing approach, quality components, and system-level design considerations can be found here.

It is important to understand that certification only has meaning within the context of the standard being applied. Testing bodies evaluate products against different standards depending on intended use. Some certifications apply to general electrical equipment, lighting products, or horticultural devices. While appropriate for those categories, such certifications do not evaluate the safety requirements of medical electrical equipment used around people.

Medical-grade certification requires system-level evaluation against all applicable requirements of the relevant medical electrical equipment standards. Partial testing, component-level evaluation, or selective application of individual requirements does not provide the same level of safety verification.

Independent certification also includes ongoing compliance requirements, such as periodic factory audits and manufacturing reviews, to ensure the certified device continues to match the approved design and safety documentation over time.

This means certification is not a one-time test, but a continuous verification process that helps ensure long-term safety and reliability for users.

What Medical-Grade Does Not Mean

Medical-grade is often confused with terms that sound authoritative but serve different purposes.

FDA registration is a regulatory requirement for many products sold in the United States. It does not evaluate or certify device safety, performance, or engineering quality.

High irradiance or power output does not determine whether a device is safe, reliable, or medically engineered.

Individual measurements such as EMF levels, light output, or wavelength verification describe specific characteristics of a device, but they do not assess electrical safety, fault conditions, thermal behavior, usability, or long-term reliability of the complete system.

Medical-grade designation depends on comprehensive, independent evaluation of the entire device system, not isolated test results.

Claims about performance, safety, or testing should be supported by independent, third-party certification of the finished device. Without verified safety certification, there is no way for consumers to confirm whether a product has been evaluated beyond isolated measurements or internal testing. Independent safety certification refers to certification issued by a Nationally Recognized Test Laboratory for the complete medical electrical device system.

Why Safety Standards Require Higher-Quality Components

Meeting medical electrical equipment safety standards is not a paperwork exercise. Devices must be designed from the ground up, following a risk-based approach.

This often requires higher-quality components, such as medical-grade power supplies, robust electrical insulation, durable enclosures, and carefully engineered control systems. These components are selected to ensure stable performance, fault tolerance, and safe operation over time.

Lower-quality components may function under ideal conditions but fail safety evaluations designed to simulate real-world use, component failures, and abnormal operating scenarios. Medical electrical equipment testing evaluates how devices behave when things do not go as planned, including electrical faults, thermal stress, and material degradation over time.

This level of testing and certification exists to help ensure a safe experience for the user, not simply to achieve strong performance metrics under controlled conditions.

A Medical-Grade Approach to Red Light Therapy

A medical-grade approach prioritizes safety, consistency, and reliability over simplified performance claims. It recognizes that red light therapy devices are electrical systems used around people and should be evaluated accordingly.

Joovv’s approach is built around:

• Engineering devices as complete systems for home and professional use. 

• Implementation of Risk Management throughout the entire engineering process.

• Selection of critical components that meet or exceed medical standards.
  

• Complete third-party Verification & Validation by a Nationally Recognized Test Laboratory (NRTL).
  

• Manufacturing under a Medical Quality Control System.
  

This approach reflects what is required for a product to be considered medical-grade in practice, not just in name.

Final Thoughts

Medical-grade is not defined by output numbers, isolated tests, or generalized certification language. It is defined by whether a device has been independently evaluated against recognized medical electrical equipment safety and performance standards, within the proper scope and application.

Understanding what goes into this level of testing helps clarify the difference between consumer electronics and devices designed for safe, reliable use around people.

That distinction matters.