--- title: Is Solius Pro FDA-cleared? description: Class II medical device. 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. --- [Skip to content](https://help.solius.com/faq/is-solius-pro-fda-cleared#main-content) [![sol-logo-primary-rgb-reg-black - email small](https://help.solius.com/hs-fs/hubfs/sol-logo-primary-rgb-reg-black%20-%20email%20small.png?width=148&height=30&name=sol-logo-primary-rgb-reg-black%20-%20email%20small.png)](https://solius.com?hsLang=en) - [Get Started](https://www.solius.com/get-started) - [User Manual](https://www.solius.com/user-manual) - [Clinical Research](https://www.solius.com/research) - [Contact Us](https://www.solius.com/contact) Open main navigation Close main navigation - [Get Started](https://www.solius.com/get-started) - [User Manual](https://www.solius.com/user-manual) - [Clinical Research](https://www.solius.com/research) - [Contact Us](https://www.solius.com/contact) How can we help you? - There are no suggestions because the search field is empty. 1. [Solius Knowledgebase](https://help.solius.com/faq?hsLang=en) 2. [Solius Technology](https://help.solius.com/faq/solius-technology?hsLang=en) # 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" as described [here](https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved). 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. [![Group 3-2](https://help.solius.com/hs-fs/hubfs/Group%203-2.png?width=195&height=50&name=Group%203-2.png "Group 3-2")](https://www.solius.com?hsLang=en) Solius is an FDA-cleared over-the-counter (OTC) UVB light panel intended to stimulate production of vitamin D in people 22 years and older. Solius is clinically proven to stimulate the production of vitamin D. References to the benefits of sunlight, UVB light, and vitamin D are based upon published, peer-reviewed research. The Solius device is not intended to diagnose, treat, cure, or prevent disease, except for the indications for use described in the user manual for your applicable region. Solius does not provide specific medical advice to users. Users should seek advice from a qualified physician or healthcare provider. This website does not establish a doctor-patient relationship. For detailed product information please consult the User Manual prior to use. Solius® is a registered trademark of Solius Labs, Inc., 100 Ravine Lane NE, Suite 310, Bainbridge Island, WA 98110 © 2026 Solius Labs, Inc.