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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunlamp Products (Pre-Standard)
510(k) Number K252960
Device Name SOLIUS PRO UVB Light Panel
Applicant
Solius Labs, Inc.
100 Ravine Lane
Suite 310
Bainbridge Island,  WA  98110
Applicant Contact Chris Kiple
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy., Suite 510(K)
Laguna Nuguel,  CA  92677
Correspondent Contact Shepard Bentley
Regulation Number878.4635
Classification Product Code
RAB  
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
Type Traditional
Clinical Trials NCT04780776
NCT04865432
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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