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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K210004
Device Name i8 Tanning Booth
Applicant
Ultrasun International B.V.
Granaatstraat 6
Hengelo,  NL 7554
Applicant Contact Tim Leusink
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy.
Suite 510(K)
Laguna Niguel,  CA  92677
Correspondent Contact Shepard G. Bentley
Regulation Number878.4630
Classification Product Code
FTC  
Subsequent Product Code
LEJ  
Date Received01/04/2021
Decision Date 12/10/2021
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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