510(k) · Cleared
ClearedHarpo Sunbed, Sun Tanning Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harpo Industries · LEJ Booth, Sun Tan
Cleared on Sep 6, 1994 after a 25-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 6, 1994
- Review
- 25 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK944015 Harpo Sunbed, Sun Tanning MachineHarpo Industries · 1994
- Descendant · cites it directly · 0 of its ownK181455 ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK152452 Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200Medtek Lighting Corp D/B/A Peacock Tanning · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944015 | Harpo Sunbed, Sun Tanning Machine | Harpo Industries | 1994 | — |
| +1 | K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | 2018 | 2 |
| +1 | K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | Medtek Lighting Corp D/B/A Peacock Tanning | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K181455 (Prosun International, LLC, 2018) has gone furthest, with 0 descendants 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.
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 | — |
https://510kreport.com/device/K944015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944015: Harpo Sunbed, Sun Tanning Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944015
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026