510(k) · Cleared
ClearedUV 8001K, Puva 800, Puva 180/200 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldmann Lighting Co. · KGL Cabinet, Phototherapy (Puva)
Cleared on Aug 30, 1984 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.
- Decided
- Aug 30, 1984
- Review
- 120 days
- Class
- Class II
- Product code
- KGL
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 1 citing it directly.
- This deviceK841795 UV 8001K, Puva 800, Puva 180/200 1000Waldmann Lighting Co. · 1984
- Descendant · cites it directly · 47 of its ownK051259 Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005
- Descendant · 2 generations on · 46 of its ownK090762 LEDAQuantel Derma GmbH · 2009
- Descendant · 3 generations on · 24 of its ownK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · 4 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 4 generations on · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K051259Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005 · cites it directly47descendants
- K090762LEDAQuantel Derma GmbH · 2009 · 2 generations on46descendants
- K200104OxylightRaja Trading Company, Inc. · 2020 · 3 generations on24descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 4 generations on16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841795 | UV 8001K, Puva 800, Puva 180/200 1000 | Waldmann Lighting Co. | 1984 | — |
| +1 | K051259 | Versaclear Skin Therapy System, Model 100 | Theralight, Inc. | 2005 | — |
| +2 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| +3 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +4 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +4 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051259 | Versaclear Skin Therapy System, Model 100 | 2005 | 47 |
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?
- Of its descendants, K051259 (Theralight, Inc., 2005) has gone furthest, with 47 descendants of its own.
How does its category compare?
All KGL devicesKGL Cabinet, Phototherapy (Puva): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGL
FDA has decided no KGL device since 2007.
Median 510(k) review, days · KGL
Too few KGL 510(k)s in any year since 2007 to give a median.
Recalls per year · KGL
No recall names KGL since 2007.
Adverse event reports per year · KGL
2in 2015
MAUDE reports naming product code KGL, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K841795 · printed Nov 5, 2026
Cite this page
510(k) Report. “K841795: UV 8001K, Puva 800, Puva 180/200 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K841795
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026