510(k) K252960
K252960 is an FDA 510(k) premarket notification submitted by Solius Labs, Inc. for the device "SOLIUS PRO UVB Light Panel". The FDA issued a decision of Substantially Equivalent on Jan 16, 2026. The device falls under product code SGZ (Ultraviolet Lamp Products), a Class II device regulated under 21 CFR 878.4635.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 2026
- Date Received
- Sep 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultraviolet Lamp Products
- Device Class
- Class II
- Regulation Number
- 878.4635
- Review Panel
- SU
- Submission Type
An ultraviolet lamp product intended to stimulate the production of Vitamin D