K210004 is an FDA 510(k) clearance for the i8 Tanning Booth. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Ultrasun International B.V. (Hengelo, NL). The FDA issued a Cleared decision on December 10, 2021, 340 days after receiving the submission on January 4, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K210004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2021 |
| Decision Date | December 10, 2021 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTC - Light, Ultraviolet, Dermatological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4630 |