510(k) K210004

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

K210004 is an FDA 510(k) premarket notification submitted by Ultrasun International B.V. for the device "i8 Tanning Booth". The FDA issued a decision of Substantially Equivalent on December 10, 2021. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.