510(k) · Cleared
ClearedUV Lamps for Sunlamp Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feilo Sylvania Germany GmbH · LEJ Booth, Sun Tan
Cleared on Jun 22, 2018 as substantially equivalent to K152273 (Cosmedico Light, Inc., 2015) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 22, 2018
- Review
- 113 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853545 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853545 | Flourescent T12 Uva Tanning Lamp | Light Sources, Inc. | 1985 | — |
| −1 | K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | 2015 | — |
| 0 (this device) | K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 2015 | 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 5.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K152273 | Cosmedico Ultraviolet Lamps of Various ModelsSummary page 5…Factory: Erlangen Germany / Erlangen Germany / Cosmedico / Light Sources Code/K LEJ, K180581 / LEJ 9-2-14 exempt I LEJ, K152273 I LEJ, K151370 Indication: UV light to tan skin / UV light to tan skin /UV light to tan skin / UV light to tan skin… | 2015 |
| * | K151370 | UV Lamps for Indoor Tanning DevicesSummary page 5…and controlled by Feilo Sylvania Germany at the same Havells location in Erlangen, Germany 2. Kl52273 Cosmedico Light, Inc., dated October 30, 2015 3. K151370 Light Sources Incorporated dated December 17, 2015 The listed UV sunlamps devices made by Feilo Sylvania at the previously owne… | 2015 |
| * | — | Havells Sylvania Germany / SLI Lichtsysteme GmbH UV sunlamps Named without a submission number |
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?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 30.2 years on median.
- None of the 8 ancestors has a recall.
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?
This ultraviolet lamp is intended for use in sunlamp products for tanning of 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/K180581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180581: UV Lamps for 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/K180581
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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