The following data is part of a premarket notification filed by Ultrasun International B.v. with the FDA for I8 Tanning Booth.
| Device ID | K210004 |
| 510k Number | K210004 |
| Device Name: | I8 Tanning Booth |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Ultrasun International B.V. Granaatstraat 6 Hengelo, NL 7554 |
| Contact | Tim Leusink |
| Correspondent | Shepard G. Bentley Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-12-10 |