Home / 510(k) Clearances / K252960

510(k) K252960

SOLIUS PRO UVB Light Panel by Solius Labs, Inc. — Product Code SGZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 16, 2026
Date Received: September 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