510(k) · Cleared
ClearedTanthera-T35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tanthera, Inc. · LEJ Booth, Sun Tan
Cleared on May 29, 2009 as substantially equivalent to K800744 (Sun Ind., Inc., 1980) after a 64-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- May 29, 2009
- Review
- 64 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K800744 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK800744 Suntana Sunbed #SB-1 & Sunbrella #SU-1Sun Ind., Inc. · 1980
- This deviceK090831 Tanthera-T35Tanthera, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800744 | Suntana Sunbed #SB-1 & Sunbrella #SU-1 | Sun Ind., Inc. | 1980 | — |
| 0 (this device) | K090831 | Tanthera-T35 | Tanthera, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K800744 | Suntana Sunbed #SB-1 & Sunbrella #SU-1Summary page 3…o follow the tanning instructions as provided in the User Manual. Section 15.4 - Predicate Device *Suntana SunSystem SunBed and SunBrella, FDA 5 10(k) Reference Number K800744, Output Range: UVA-only *Currently marketed UVAl bulb shown to effectively tan: Philips TLI0 *Substantial Equivalence Comparison:… | 1980 |
| * | — | Philips TL10 UVA1 lamp 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.
How does its category compare?
All LEJ devicesLEJ Booth, Sun Tan: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Intended to provide ultraviolet light to tan the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090831 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090831: Tanthera-T35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090831
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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