Bainbridge Island, WA - March 11, 2026 - Solius Labs today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Solius Pro, the first medical device designed to deliver the beneficial ultraviolet-B (UVB) spectrum of sunlight with personalized, medical-grade precision.
Solius is cleared as a Class II medical device under a new FDA product code, SGZ - Ultraviolet lamp products, placing it in a distinct regulatory category of its own.
FDA clearance allows Solius to be marketed over-the-counter (OTC), expanding access to controlled, clinically validated sunlight therapy year-round. As the first and only device in its category, Solius enters the market with strong early demand, including more than 1,000 devices already committed through pre-orders. Solius is now available to order, with initial limited quantity U.S. shipments starting in April for both home and professional use.
Unlocking Access to the Health Spectrum of Sunlight
Sunlight is foundational to human health, yet reliable access to biologically meaningful sunlight has become increasingly limited by modern indoor lifestyles, seasonal variation, geography, and safety concerns. Leading public health researchers have warned that insufficient sun exposure has become a significant and growing global health problem.
UVB is the most biologically powerful ultraviolet spectrum available on Earth but can cause skin and eye damage if not carefully controlled, which is why devices that emit UVB are regulated. As a result, UVB exposure has historically been difficult to dose safely and has largely been limited to dermatologic use under physician supervision, requiring a narrow balance between meaningful biological benefit and potential risk.
Only a small fraction of natural sunlight energy that reaches Earth - less than 1% - contains UVB wavelengths responsible for hormone production and downstream biological effects. Most solar energy is visible light, infrared heat, and UVA.
Even on clear, sunny days in the summer, UVB availability varies dramatically based on season, latitude, time of day, and sun angle, making it difficult to achieve a consistent beneficial dose from natural sunlight. Solius is engineered to deliver the most biologically valuable portion of sunlight - without unnecessary exposure to the broader solar spectrum.
Solius concentrates 95% of its output within the UVB action spectrum, delivering more UVB biological benefit than the sun with less than 1% total UV exposure. To put this into perspective, a full year of once-weekly Solius sessions delivers approximately the same total UV radiation as about five minutes of natural midday sunlight.
Solius delivers 12x more UVB biological benefit compared to afternoon sun at mid-latitude locations, where meaningful UVB exposure is often minimal.
Sunlight is Foundational to Health Beyond Vitamin D
A growing body of peer-reviewed research indicates that sunlight is more than a vitamin D source. When the skin absorbs UVB energy, it converts that energy into hormones and signaling molecules that influence communication across multiple physiological systems.
Through the skin-brain axis, UVB-driven signals influence mood, cognition, energy balance, circadian regulation, and emerging research suggests a role in long-term neuroprotection. Through the skin-gut axis, UVB-generated metabolites support microbiome regulation, gut barrier integrity, immune modulation, and metabolic resilience.
Within seconds of exposure, UVB initiates the skin’s vitamin D production process. Over the next 24-48 hours, vitamin D becomes active as a hormone influencing more than 1,000 genes involved in skeletal strength, immune defense, and metabolic regulation.
Research suggests many sunlight-associated benefits are not replicated through oral supplementation alone, indicating that vitamin D serves as a biomarker for a broader UVB-driven biological cascade.
“Sunlight is a foundational biological signal, not just a source of vitamin D,” said Dr. Michael F. Holick, PhD, MD, Professor of Medicine at Boston University. “Measured UVB light exposure may be particularly valuable for individuals who have difficulty absorbing vitamin D through oral supplements. Research also suggests that UVB light exposure may offer additional health benefits, including preserving bone strength, reducing blood pressure, reducing risk for immune disorders, improving mood and cognition, as well as promoting metabolic and immune health.”
Personalized Dosing Through Breakthrough Sensor Technology
Achieving the 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 proprietary skin analysis and dosing system that evaluates individual skin characteristics and automatically calibrates a personalized UVB dose for each user.
Therapy is delivered once per week to exposed skin on the back, lasts approximately five minutes, and is managed through a mobile application with built-in safety controls to ensure consistent and repeatable dosing across all skin types.
Clinical Validation and Expert Perspective
In three human clinical studies, Solius demonstrated the ability to safely deliver personalized UVB doses without erythema, skin irritation, or adverse events.
In a randomized controlled trial published in Anticancer Research, users of Solius experienced an average increase of 10 ng/mL in serum vitamin D levels without skin damage or visible tanning.
“Solius medical 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 Dermatology at the University of British Columbia. “This represents a meaningful advancement in dermatology and medical phototherapy.”
“Many of us have avoided sunlight to reduce skin cancer risk, but in doing so we may also reduce access to biological benefits that UVB provides,” said Chris Kiple, Chief Executive Officer of Solius Labs. “Solius is designed to bring the key health spectrum of sunlight safely and consistently. Our clinical data supports the potential for Solius to meaningfully improve health outcomes for people worldwide.”
About Solius Labs
Solius Labs is the world’s first Precision Sunlight company, developing medical-grade light technologies that safely replicate the biological benefits of natural sunlight year-round. By combining a targeted healthy UVB spectrum, personalized dosing, and clinical validation, Solius is redefining how UVB light is used to support human health.