510(k) · Cleared
ClearedPeacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek Lighting Corp D/B/A Peacock Tanning · LEJ Booth, Sun Tan
Cleared on May 19, 2016 as substantially equivalent to K944015 (Harpo Industries, 1994) and 1 other predicate after a 265-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 19, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- LEJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871237 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK871237 Sun Capsule I & II Suntanning BoothSun Capsule, Inc. · 1987
- This deviceK152452 Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200Medtek Lighting Corp D/B/A Peacock Tanning · 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) | K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | Medtek Lighting Corp D/B/A Peacock Tanning | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 5.1 · 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 |
|---|---|---|---|
| * | K944015 | Harpo Sunbed, Sun Tanning MachineSummary page 5…erce: 1. Primary Predicate: K Number (NONE)-ACCESSION NUMBER: 8920525, PEACOCK TANNING EXPRESS TAN MODELS 1000/1600/2000/3200 (MEDTEK LIGHTING CORP) 2. K944015 - HARPO SUNBED, SUN TANNING MACHINE (HARPO INDUSTRIES) 1994 clearance, Product Code:LEJ 3. K871237 - SUN… | 1994 |
| * | K871237 | Sun Capsule I & II Suntanning BoothSummary page 6…/2000/3200 (MEDTEK LIGHTING CORP) 2. K944015 - HARPO SUNBED, SUN TANNING MACHINE (HARPO INDUSTRIES) 1994 clearance, Product Code:LEJ 3. K871237 - SUN CAPSULE I & II SUNTANNING BOOTH (SUN CAPSULE, INC) 1987 clearance, Product Code:FTC 6. Substantial Equivalence to P… | 1987 |
| * | — | Peacock Tanning Express Tan Models 1000/1600/2000/3200 (Medtek Lighting Corp) 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?
- None of the 2 ancestors has a 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. 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?
Medtek Lighting, LLC's Peacock Tanning, Express Tan Models 1000HT, 1600HT, 2000CT, 2000HT, 3200 are intended
to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152452: Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152452
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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