510(k) · Cleared
Cleared3 Series Phototherapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daavlin Distributing Company · FTC Light, Ultraviolet, Dermatological
Cleared on Jun 30, 2016 as substantially equivalent to K063621 (Daavlin Co., 2007) after a 184-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it.
- Decided
- Jun 30, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K828654 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 1 generation backK063621 3 Series Phototherapy CabinetDaavlin Co. · 2007
- This deviceK153749 3 Series Phototherapy UnitDaavlin Distributing Company · 2016
- Descendant · cites it directly · 1 of its ownK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
- Descendant · 2 generations on · 0 of its ownK261775 Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| −1 | K063621 | 3 Series Phototherapy Cabinet | Daavlin Co. | 2007 | — |
| 0 (this device) | K153749 | 3 Series Phototherapy Unit | Daavlin Distributing Company | 2016 | — |
| +1 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
| +2 | K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K063621 | 3 Series Phototherapy CabinetSummary page 4…t Full Body Phototherapy Unit 21 CFR 878.4630 Ultraviolet lamp for dermatologic disorders Class I FTC General and Plastic Surgery 3 Series SP/PC Phototherapy Unit K063621 FTC Daavlin Distributing Company Device Description: The 3 Series NeoLux Phototherapy Unit is a full body medic… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230382 | 3 Series NeoLux | 2023 | 1 |
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 33 years and passes through 2 companies; a new generation was cleared every 24.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230382 (Daavlin Distributing Co., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K063621.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 NeoLux, 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/K153749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153749: 3 Series Phototherapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153749
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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