510(k) · Cleared
ClearedUV Phototherapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Kernel Medical Equipment Co., Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on Jan 30, 2014 after a 157-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 30, 2014
- Review
- 157 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK132643 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK181805 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK223882 Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)Shenzhen Honpal Optoelectronic Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK191571 UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK242908 UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD…Shanghai Sigma High-Tech Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K181805UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2019 · cites it directly3descendants
- K223882Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)Shenzhen Honpal Optoelectronic Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K191571UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2020 · 2 generations on1descendant
- K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…Shanghai Sigma High-Tech Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132643 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014 | — |
| +1 | K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019 | — |
| +2 | K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | 2023 | — |
| +2 | K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020 | — |
| +3 | K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD… | Shanghai Sigma High-Tech Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 FTC? 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 FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | DermaPal Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181805 | UV Phototherapy | 2019 | 3 |
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, K181805 (Xuzhou Kernel Medical Equipment Co., Ltd., 2019) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, 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 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006, delivers ultraviolet (UV) light to targeted affected skin. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
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/K132643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132643: UV Phototherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132643
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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