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510(k) K210004

i8 Tanning Booth by Ultrasun International B.V. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2021
Date Received
January 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

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