i8 Tanning Booth— 510(k) K210004

Substantially Equivalent

Ultrasun International B.V.

FDA 510(k) clearance K210004 for i8 Tanning Booth, Substantially Equivalent on 2021-12-10. Applicant: Ultrasun International B.V.. Device class: 2.

Clearance details

Applicant: Ultrasun International B.V.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2021-01-04
Decision date: 2021-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hengelo, NL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.