K252960 is an FDA 510(k) clearance for the SOLIUS PRO UVB Light Panel. This device is classified as a Ultraviolet Lamp Products (Class II - Special Controls, product code SGZ).
Submitted by Solius Labs, Inc. (Bainbridge Island, US). The FDA issued a Cleared decision on January 16, 2026, 122 days after receiving the submission on September 16, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635. An Ultraviolet Lamp Product Intended To Stimulate The Production Of Vitamin D.
| 510(k) Number | K252960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SGZ - Ultraviolet Lamp Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4635 |
| Definition | An Ultraviolet Lamp Product Intended To Stimulate The Production Of Vitamin D |