FDA-Cleared Manufacturer vs. FDA-Cleared Device
FDA-Cleared Manufacturer:
Our LED light therapy mask is made in a facility that has received FDA clearance. This means the manufacturer follows strict FDA standards in areas such as safety protocols, quality control, sterile production environments, documentation, and testing. In short, they are authorized to produce medical-grade devices under rigorous oversight.
FDA-Cleared Device:
When a device is FDA cleared, it means that specific product has undergone an application and review process with the FDA to prove it is "substantially equivalent" to another legally marketed device. This involves submitting performance data, clinical results, and other documentation to validate claims about the device’s effectiveness and safety.
So, while an FDA-cleared manufacturer builds the product to medical-grade standards, a device must go through its own costly and time-consuming approval process to be individually cleared by the FDA.
Why Our Devices Aren’t FDA Cleared—Yet
As a small, independent brand, seeking FDA clearance on our own version of an LED mask requires a significant investment—often well into the upper tens of thousands of dollars, along with lengthy timelines. At this stage, we’ve chosen to focus on product development, practitioner education, and delivering a quality experience at an accessible price.
We did ensure that our manufacturing partner already meets FDA standards. That means every TOMA mask is created in a facility that produces cleared medical devices and adheres to the highest standards of production.
In fact, our device is built with the same specifications—such as wavelength, power density (irradiance), and safety features—as many devices that are FDA cleared.
What This Means for You
While our TOMA LED Mask is not itself FDA cleared, it is:
- Manufactured in an FDA-cleared facility
- Built to professional-grade standards
- Is insured, as all of our equipment and products are
- Safe for home use with no downtime or discomfort
- Designed with clinically studied wavelengths
- Supported by transparent education, science, and real-world results
We are committed to transparency and integrity. As we grow, seeking FDA clearance for our device may be part of our future plans—but for now, our priority is delivering high-quality, affordable LED technology that empowers professionals and home users alike.
