510(k) · Cleared
ClearedUV Radiation Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Yongkang Electronic Science Technology Co., Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on Feb 6, 2020 as substantially equivalent to K181805 (Xuzhou Kernel Medical Equipment Co., Ltd., 2019) after a 237-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Feb 6, 2020
- Review
- 237 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132643 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK132643 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2014
- 1 generation backK181805 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2019
- This deviceK191571 UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK242908 UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD…Shanghai Sigma High-Tech Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…Shanghai Sigma High-Tech Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132643 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014 | — |
| −1 | K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019 | — |
| 0 (this device) | K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K181805 | UV PhototherapySummary page 4…l: General& Plastic Surgery 4.0 Predicate device information Manufacturer: Xuzhou Kernel Medical Equipment Co., LTD. Device: UV Phototherapy 510(k) number: K181805 6-1 K191571… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD… | 2024 | 0 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K242908 (Shanghai Sigma High-Tech Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181805.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Radiation Treatment System models YK-6000A, YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitiligo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191571: UV Radiation Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191571
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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