510(k) · Cleared
Cleared3 Series Phototherapy Cabinet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daavlin Co. · FTC Light, Ultraviolet, Dermatological
Cleared on Jan 17, 2007 as substantially equivalent to K828654 (Daavlin Co., 1983) after a 43-day review. Its family tree reaches back 1 generation to 1983. 7 later devices descend from it.
- Decided
- Jan 17, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K828654 (1983). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- This deviceK063621 3 Series Phototherapy CabinetDaavlin Co. · 2007
- Descendant · cites it directly · 2 of its ownK153749 3 Series Phototherapy UnitDaavlin Distributing Company · 2016
- Descendant · 2 generations on · 1 of its ownK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
- Descendant · cites it directly · 1 of its ownK110912 Smart Touch Uvtherapy Multiple MachineDaavlin Distributing Co. · 2011
- Descendant · 3 generations on · 0 of its ownK261775 Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK150912 Houva-NET Control SystemNational Biological Corporation · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1537493 Series Phototherapy UnitDaavlin Distributing Company · 2016 · cites it directly2descendants
- K2303823 Series NeoLuxDaavlin Distributing Co. · 2023 · 2 generations on1descendant
- K110912Smart Touch Uvtherapy Multiple MachineDaavlin Distributing Co. · 2011 · cites it directly1descendant
- K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
- K150912Houva-NET Control SystemNational Biological Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| 0 (this device) | K063621 | 3 Series Phototherapy Cabinet | Daavlin Co. | 2007 | — |
| +1 | K153749 | 3 Series Phototherapy Unit | Daavlin Distributing Company | 2016 | — |
| +2 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
| +1 | K110912 | Smart Touch Uvtherapy Multiple Machine | Daavlin Distributing Co. | 2011 | — |
| +3 | K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K150912 | Houva-NET Control System | National Biological Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Summary page 1…Distributing Company Spectra 300 Series Ultraviolet Phototherapy Cabinet K828654 petsén/ e Daavlin Distributing Company 3 Series S Phototherapy Cabinet Ultraviolet Phototherapy Cabinet K04250… | 1983 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 3 Series PC & SP, full body phototherapy device, is a medical ultraviolet cabinet, which is intended 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/K063621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063621: 3 Series Phototherapy Cabinet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063621
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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