510(k) · Cleared
ClearedKBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Oct 28, 2019 as substantially equivalent to K151962 (Kbl AG, 2016) after a 105-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Oct 28, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151962 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK151962 KBL Sunlamp Products (= Device Bundling name)Kbl AG · 2016
- This deviceK191881 KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha…Kbl GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151962 | KBL Sunlamp Products (= Device Bundling name) | Kbl AG | 2016 | — |
| 0 (this device) | K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Kbl GmbH | 2019 | — |
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 LEJ? 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 LEJ device
- #1 K221523 Tanning Lampscore 5.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K151962 | KBL Sunlamp Products (= Device Bundling name)Summary page 5…General & Plastic Surgery Device Class Class II - Special Controls 510(k) No. K151962 4. DEVICE DESCRIPTION KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structur… | 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 LEJ devicesLEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LEJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LEJ
105in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEJ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEJ
1in 2025
MAUDE reports naming product code LEJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 9 | 102 | 0 | 4 |
| 2016 | 11 | 247 | 0 | 0 |
| 2017 | 1 | — | 1 | 9 |
| 2018 | 6 | 106 | 0 | 4 |
| 2019 | 3 | 105 | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for 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/K191881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191881: KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191881
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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