510(k) · Cleared
ClearedUV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Sigma High-Tech Co., Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on Dec 19, 2024 as substantially equivalent to K223882 (Shenzhen Honpal Optoelectronic Technology Co., Ltd., 2023) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 2014.
- Decided
- Dec 19, 2024
- Review
- 86 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K132643 (2014). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK132643 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2014
- 2 generations backK181805 UV PhototherapyXuzhou Kernel Medical Equipment Co., Ltd. · 2019
- 1 generation backK191571 UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2020
- This deviceK242908 UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD…Shanghai Sigma High-Tech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132643 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014 | — |
| −2 | K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019 | — |
| −1 | K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD… | Shanghai Sigma High-Tech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)Summary page 5…r 878.4630 Product Code(s) FTC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223882 Narrowband UV Phototherapy Light Lamp FTC K191571 UV Radiation Treatment System FTC K170489 Clarify Medical Phototherapy System… | 2023 |
| * | K191571 | UV Radiation Treatment SystemSummary page 5…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223882 Narrowband UV Phototherapy Light Lamp FTC K191571 UV Radiation Treatment System FTC K170489 Clarify Medical Phototherapy System FTC K040062 / KO90097 | | Levia Ph… | 2020 |
| † | K170489 | Skylit Phototherapy System | 2017 |
| † | K040062 | Levia Phototherapy System | 2004 |
| † | K090097 | LH-75T Phototherapy System | 2009 |
| † | K200971 | 308nm Excimer System | 2020 |
| † | K192642 | 308nm Excimer System | 2020 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.
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/K242908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242908: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242908
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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