510(k) · Cleared
Clearedi8 Tanning Booth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrasun International B.V. · FTC Light, Ultraviolet, Dermatological
Cleared on Dec 10, 2021 as substantially equivalent to K152405 (Ibl Acquisitions, LLC, 2016) after a 340-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Dec 10, 2021
- Review
- 340 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K152405 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK152405 IBL 5000 Tanning BoothIbl Acquisitions, LLC · 2016
- This deviceK210004 i8 Tanning BoothUltrasun International B.V. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K152405 | IBL 5000 Tanning Booth | Ibl Acquisitions, LLC | 2016 | — |
| 0 (this device) | K210004 | i8 Tanning Booth | Ultrasun International B.V. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152405 | IBL 5000 Tanning BoothSummary page 5…FR §878.4635) Classification Panel: General Surgery Devices (DHT4A) Device Class: Class II – Special Controls 510(k) Number: K152405 4. DEVICE DESCRIPTION Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210004: i8 Tanning Booth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210004
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026