Published June 2026 in Medtech Insight
Article Excerpt
Solius Labs launched Solius Pro on June 17, a wall-mountable UVB light panel that the U.S. Food and Drug Administration cleared in January for over-the-counter use, making it the first FDA-cleared UVB light therapy device available without a prescription. “It was tremendously difficult,” CEO Chris Kiple said in an interview with Medtech Insight. “The level of rigor and review was substantial. We had to provide both safety and efficacy data to the FDA to really show that there was a risk-benefit.”
The company’s background in developing novel life-support products for ICU and critical care environments did not make the phototherapy clearance process any easier. Kiple noted that Solius Pro was even more challenging to bring through the FDA than some critical care devices. The FDA cleared Solius Pro as a Class II medical device under a newly established product code, SGZ. Its indications for use are narrowly defined: stimulating vitamin D production in adults aged 22 and older.
While the FDA-cleared indication focuses on vitamin D, the company points to a growing body of peer-reviewed UVB research exploring broader effects on mood, cognition, cardiovascular health, immune function, and the microbiome. The Technical Innovation Behind the Clearance At the center of Solius Pro is a skin-sensing system that enables personalized UVB dosing, a feature that proved critical to the FDA clearance process.
The device uses an optical color sensor to analyze the user’s skin and calculate a personalized UVB dose based on skin type and melanin content. Kiple explained that the sensor was developed using a large dataset of skin samples collected from seven laboratories around the world, combined with user feedback and multiple in-human clinical studies.
“From our in-human clinical studies, we were able to determine that 100% of the time we were able to provide a safe dose of UVB light therapy that also had a clinical benefit to those individuals,” Kiple said. “This is the first time a skin sensor like this has been approved by the FDA.” The system delivers UVB radiation with a peak wavelength of 293 nanometers, near the peak of the vitamin D action spectrum. A typical therapy session lasts approximately five minutes once per week.
Solius Pro also incorporates multiple layers of safety technology, including: Integrated distance sensors AI-assisted protective eyewear detection Personalized dose calculations Mobile app-guided therapy management Real-time session monitoring and feedback Chris Brooks, Chief Strategy Officer of Solius, noted that achieving over-the-counter clearance required an even higher regulatory standard than many prescription medical devices.
“There are dozens of safety features built in seamlessly to the device, either in the back end or in the user experience, to make sure that the user is going through the setup process and the therapy process in an appropriate way such that they can be safe throughout their experience.” The result is a new category of FDA-cleared phototherapy technology designed to bring personalized UVB light therapy directly into the home without requiring a prescription or physician supervision.
