510(k) · Cleared
Recalled · Class II · 2018ProSun sunlamp products, Luxura sunlamp products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosun International, LLC · LEJ Booth, Sun Tan
Cleared on Sep 10, 2018 as substantially equivalent to K944015 (Harpo Industries, 1994) after a 98-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- Sep 10, 2018
- Review
- 98 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944015 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944015 Harpo Sunbed, Sun Tanning MachineHarpo Industries · 1994
- This deviceK181455 ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944015 | Harpo Sunbed, Sun Tanning Machine | Harpo Industries | 1994 | — |
| 0 (this device) | K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | 2018 | — |
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 |
|---|---|---|---|
| * | K944015 | Harpo Sunbed, Sun Tanning MachineSummary page 8…Prosun 12 /24 24 Series 12V Canopy Tanner Series 9520183‐008 9212092‐00 K944015 24J 24 Series JADE 24 Jade 24 Prosun 24 Series 9520183‐008 9520183‐04 K944015 24… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2018 | Class II | Z-1177-2019 | Employee error | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. |
| Dec 10, 2018 | Class II | Z-1176-2019 | Employee error | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944015.
How does its category compare?
All LEJ devicesLEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Tanning Bed Systems are intended to provide tanning of the human skin.
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/K181455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181455: ProSun sunlamp products, Luxura 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/K181455
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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