510(k) · Cleared
ClearedSun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Capsule, Inc. · LEJ Booth, Sun Tan
Cleared on Mar 4, 2016 as substantially equivalent to K871237 (Sun Capsule, Inc., 1987) after a 207-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Mar 4, 2016
- Review
- 207 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871237 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK871237 Sun Capsule I & II Suntanning BoothSun Capsule, Inc. · 1987
- This deviceK152238 Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule…Sun Capsule, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871237 | Sun Capsule I & II Suntanning Booth | Sun Capsule, Inc. | 1987 | — |
| 0 (this device) | K152238 | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6… | Sun Capsule, Inc. | 2016 | — |
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? (2)
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 |
|---|---|---|---|
| * | K871237 | Sun Capsule I & II Suntanning BoothSummary page 5…l devices listed in Section 2.3 of this 510k Summary- ACCESSION NUMBER: 1531591-000. Secondary Predicate Devices: 1. Sun Capsule Tanning Booths 1& 2, Suncapsule, Inc, K871237: 1987 *All of the devices included in this submission existed and were legally marketed prior to September 2, 2014. FDA accessio… | 1987 |
| * | — | All devices listed in Section 2.3 of this 510(k) Summary (Sun Capsule models; FDA… 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K871237.
How does its category compare?
All LEJ devicesLEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152238: Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152238
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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