FDA Clears Personalized UVB Device to Boost Vitamin D Production

The U.S. FDA has approved Solius Pro, a personalized UVB light therapy device designed to stimulate the body's natural production of vitamin D. The device is intended for adults aged 22 years and older and provides customized UVB exposure to help maintain adequate vitamin D levels. This approval offers a non-pharmacological option for individuals seeking to improve vitamin D status through controlled light therapy.

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.

UVB: The Most Powerful Wavelength for Human Health & Longevity

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 historically has been difficult to dose safely without skin damage, and has largely been limited to dermatologic use under physician supervision. Solius revolutionizes the delivery of UVB light therapy by measuring skin and determining a personalized dose that delivers 12x more UVB biological benefit than the sun with 99% less UV risk, now available for home and professional use.

To put this 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.

Beyond Vitamin D: The Systemic Science of Sunlight

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," said Chris Kiple, Chief Executive Officer of Solius Labs. "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.”

FDA Clearance: A New Phototherapy Technology, A New Product Code

The FDA granted clearance for Solius as a Class II medical device under a new FDA product code, SGZ, UVB light therapy to stimulate the production of vitamin D, placing it in a distinct regulatory category of its own. This clearance allows Solius to be marketed over-the-counter, expanding access to controlled, clinically validated UVB light therapy year-round.

As the first and only device in its category, Solius enters the market with strong early demand and more than 1,000 pre-orders ahead of launch. Solius is now available to order for both home and professional use at Solius.com, and is eligible for purchase using Health Savings Account (HSA) and Flexible Spending Account (FSA) funds through Truemed.

Personalized Dosing Through Breakthrough Skin Sensing Technology

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, 100% of users received a Solius UVB light dose without reporting erythema, edema, or other adverse skin reactions.

Solius therapy is delivered once-weekly 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.

Clinically Proven Safety & Efficacy

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,” said 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.”