510(k) · Cleared
ClearedErgoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jk Holding GmbH · LEJ Booth, Sun Tan
Cleared on Sep 16, 2015 after a 113-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Sep 16, 2015
- Review
- 113 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK151400 Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp…Jk Holding GmbH · 2015
- Descendant · cites it directly · 1 of its ownK190173 Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline…Jk-Holding GmbH · 2019
- Descendant · cites it directly · 1 of its ownK180555 Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH · 2018
- Descendant · cites it directly · 0 of its ownK220500 Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by…Jk-Holding GmbH · 2022
- Descendant · cites it directly · 0 of its ownK173565 Sunrise 6200, Sunrise 7200Jk-Holding GmbH · 2018
Most influential descendants
Showing 4 of 4 · See all- K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid…Jk-Holding GmbH · 2019 · cites it directly1descendant
- K180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH · 2018 · cites it directly1descendant
- K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness…Jk-Holding GmbH · 2022 · cites it directly0descendants
- K173565Sunrise 6200, Sunrise 7200Jk-Holding GmbH · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | Jk Holding GmbH | 2015 | — |
| +1 | K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550… | Jk-Holding GmbH | 2019 | — |
| +1 | K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH | 2018 | — |
| +1 | K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet… | Jk-Holding GmbH | 2022 | — |
| +1 | K173565 | Sunrise 6200, Sunrise 7200 | Jk-Holding GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
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 5.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid… | 2019 | 1 |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | 2018 | 1 |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness… | 2022 | 0 |
| K173565 | Sunrise 6200, Sunrise 7200 | 2018 | 0 |
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?
- Of its descendants, K190173 (Jk-Holding GmbH, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LEJ devicesLEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151400: Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151400
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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