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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultraviolet Lamp Products
510(k) Number K252960
Device Name SOLIUS PRO UVB Light Panel
Applicant
Solius Labs, Inc.
100 Ravine Ln.
Suite 310
Bainbridge Island,  WA  98110
Applicant Contact Chris Kiple
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy.
Suite 510(K)
Laguna Niguel,  CA  92677
Correspondent Contact Shepard Bentley
Regulation Number878.4635
Classification Product Code
SGZ  
Date Received09/16/2025
Decision Date 01/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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