--- title: "What's the difference between \"FDA registered\" and \"FDA cleared\"?" description: FDA registered means a company listed its facility, with no product review. FDA cleared means the FDA reviewed the device for safety and efficacy. --- [Skip to content](https://help.solius.com/faq/whats-the-difference-between-fda-registered-and-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) # What's the difference between "FDA registered" and "FDA cleared"? "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 product, and it says nothing about whether a device is safe or works as claimed. "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.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252960) [![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.