FDA 510(k) cleared · K252960
FDA-cleared UVB light therapy
Solius Pro is the only personalized UVB light therapy device cleared by the FDA for over-the-counter use — no prescription required. Here’s what that means, and why it matters for your safety.
Is Solius Pro FDA-cleared?
Yes — Solius Pro is an FDA-cleared over-the-counter (OTC) light panel intended to stimulate production of vitamin D in people 22 years and older.
Solius was developed and tested to Class II medical device standards and cleared by the FDA for over-the-counter use, bringing clinical precision and safety with no prescription required. This level of regulatory clearance signals that Solius meets rigorous safety and performance requirements beyond typical consumer wellness devices often listed as “FDA Registered” or “FDA Certified.”
The FDA regulates this spectrum of light and requires all UV devices to undergo regulatory review. Devices sold without FDA clearance are illegal and may not be safe.
Why does FDA clearance matter for UVB light therapy?
UVB light drives systemic health benefits, but can also cause sunburn and skin damage. The difference between a helpful dose and a harmful one can come down to seconds of exposure. That’s why, in the United States, UVB devices intended to impact human health are regulated as medical devices and must be cleared by the FDA before they can be sold.
FDA clearance is not a formality. Before clearing Solius, the FDA reviewed its safety and performance testing, its light output, its labeling, and its risks against a specific intended use. Solius is the only personalized UVB light therapy device cleared by the FDA for over-the-counter use without a prescription (510(k) K252960).
What’s the difference between “FDA registered” and “FDA cleared”?
“FDA registered”
“FDA registered” means a company has listed its facility with the FDA, but the FDA does not review the product. This is a registration of a facility, not an approval or clearance of the device — and it says nothing about whether a device is safe or works as claimed.
“FDA cleared”
“FDA cleared” means the FDA reviewed the specific device and found it safe and effective for its intended use before it could be marketed. You can look up any cleared device in the FDA’s public 510(k) database — Solius’s clearance is listed here.
Are other home UVB lamps FDA-cleared?
Many UVB lamps sold online for vitamin D and other health benefits are not FDA-cleared. Some are labeled “wellness” products or show an “FDA registered” badge, which doesn’t mean the FDA has reviewed the device. Unregulated UVB devices have drawn regulator attention: Health Canada has issued public safety notices on several unlicensed UV lamps sold for vitamin D and wellness, citing potential health risks and, in some cases, specific reports of human harm - see example 1 and example 2.
Without independent review, there’s no assurance that a device’s UV output is accurate, that it delivers a consistent dose, or that it’s safe for use.
How is Solius different from unregulated UVB lamps?
Solius was designed and tested to deliver UVB light therapy safely at home. Here are a few of the features and evidence that set it apart.
Personalized dosing
A built-in skin sensor measures your skin and calculates a personalized dose for you, instead of a single exposure time based on a general skin type category.
Precise light
UVB LEDs with a targeted peak at 293 nm, with 95% of light output within the UVB action spectrum and consistent light output across the therapy area.
Dynamic positioning
Distance sensing helps you stay at the right distance for every session, with visual guidance in the mobile app and automatic shutoff if you’re not properly positioned.
Protective eyewear
Validated UVB protective eyewear is included, and in-app detection helps ensure your eyes are protected during therapy.
Controlled usage
A required rest period between sessions helps prevent overexposure.
Clinical evidence
In a randomized controlled study published in Anticancer Research, Solius users saw an average 76% increase in vitamin D levels from baseline, with no serious adverse events.
Experience FDA-cleared light therapy at home
Clinical precision and safety, no prescription required. Personalized sunlight in under 5 minutes a week.