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Solius Pro gained FDA clearance as a Class II medical device under a new FDA product code.
August 28, 2026
By: Michael Barbella
Solius Labs has officially launched Solius Pro, the (reportedly) only U.S. Food and Drug Administration (FDA)-cleared personalized UVB light therapy device available without a prescription.
Solius uses a patent-pending skin analysis system that measures each user’s unique skin tone to determine a precise UVB dose, stimulating the sun’s natural health benefits in approximately five minutes per week. The FDA established a new product code for Solius, recognizing it as a novel health technology category and placing the device in a distinct regulatory category.
Sunlight is foundational to human health, yet insufficient sunlight exposure has become a significant and growing global health problem. Modern indoor lifestyles, geographic location, and seasonal variation limit access to essential UVB wavelengths.
UVB is the most powerful and biologically beneficial spectrum of light, but it historically has been difficult to dose safely without skin damage and has largely been limited to dermatologic use under physician supervision. Solius changes the delivery of UVB light therapy by measuring the skin and determining a personalized dose that delivers 12 times more UVB biological benefit than the sun, with 99% less UV risk, now available for home and professional use.
To put this technology risk into perspective, a full year of weekly Solius therapy is less UV exposure risk than just five minutes of afternoon sun. Additionally, Solius delivers 50% less total UV radiation than prescription narrow-band UVB devices.
A growing body of peer-reviewed research indicates that sunlight is more than a source of vitamin D. When the skin absorbs UVB light, it converts that energy into hormones and signaling molecules that influence multiple physiological systems and play a key role in fostering a diverse and healthy microbiome.
UVB light has also been clinically demonstrated to positively impact mood, energy, cognition, bone health, immune function, cardiovascular health, and metabolic resilience.
“Decades of peer-reviewed research confirm that sunlight is fundamental to human health beyond vitamin D,” Solius Labs CEO Chris Kiple said. “Solius is the first technology to deliver the health benefits of UVB light therapy with dosing personalized to each user’s skin. We are committed to bringing clinically-proven efficacy and an unprecedented standard of safety to the UVB light therapy space.”
The FDA granted clearance for Solius as a Class II medical device under a new product code—SGZ, UVB light therapy to stimulate the production of vitamin D—placing it in a distinct regulatory category of its own. The clearance allows Solius to be marketed over-the-counter, expanding access to controlled, clinically validated UVB light therapy year-round.
Achieving the health benefits of sunlight requires a narrow biological sweet spot: enough UVB to activate beneficial processes without causing skin damage.
Solius addresses this challenge with a patent-pending skin analysis and dosing system that evaluates individual skin characteristics and automatically calculates a personalized UVB dose for each user. In a clinical study performed by Eurofins Clinical Research Laboratories, all users received a Solius UVB light dose without reporting erythema, edema, or other adverse skin reactions.
Solius therapy is delivered once a week to exposed skin on the back. Each session lasts approximately five minutes and is managed through the Solius App, which includes extensive built-in safety controls to ensure precise, safe delivery for every use.
In three human clinical studies, Solius demonstrated safe delivery of personalized UVB light therapy. In a randomized controlled trial published in Anticancer Research, participants using Solius experienced an average vitamin D increase of 10.2 ng/mL, a mean individual percent change of 76% from their baseline levels.
“Solius medical UVB light therapy and dosing technology maximize the health benefits of UVB light while nearly eliminating the risks typically associated with sun exposure,” stated Dr. Dutz, M.D., professor and head of the Department of Dermatology and Skin Science at the University of British Columbia, one of the largest phototherapy clinics in North America. “This represents a meaningful advancement in dermatology and the safety of medical phototherapy.”
Solius Labs is the world’s first Personalized Sunlight company, developing FDA-cleared, medical-grade UVB light therapy technologies that safely replicate the systemic biological benefits of year-round sunlight. By combining a targeted healthy UVB spectrum, personalized dosing, and clinical validation, Solius is attempting to redefine the way UVB light is used to support human health.
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