510(k) · Cleared
ClearedUv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Kernel Medical Equipment Co., Ltd.
Cleared on Jul 21, 2026 as substantially equivalent to K230382 (Daavlin Distributing Co., 2023) after a 53-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Jul 21, 2026
- Review
- 53 days
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K828654 (1983). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 5 generations backK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- 4 generations backK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- 3 generations backK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- 2 generations backK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · Recalled
- 1 generation backK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
- This deviceK261775 Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| −5 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| −4 | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | 1 |
| −3 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| −2 | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | 1 |
| −1 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
| 0 (this device) | K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2016 | 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 this category? 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? (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 |
|---|---|---|---|
| * | K230382 | 3 Series NeoLuxSummary page 5…ation Panel: General & Plastic Surgery Product Code: FTC Device Classification: Class II Regulation Number: 21 CFR 878.4630 4. The Predicate Devices Predicate Devices K230382 3 Series NeoLux Daavlin Distributing Company 5. Device Description 5.1 Device introduction: This instrument c… | 2023 |
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 43 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
What is it indicated for?
The devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopioc dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261775: Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261775
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026