510(k) · Cleared
ClearedML24000 Uva-1 Phototherapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Daavlin Distributing Company · FTC Light, Ultraviolet, Dermatological
Cleared on Feb 22, 2011 as substantially equivalent to K041212 (National Biological Corp., 2004) after a 64-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Feb 22, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K041212 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK041212 Houva 3 Phototherapy SystemNational Biological Corp. · 2004 · Recalled
- This deviceK103708 ML24000 Uva-1 Phototherapy UnitThe Daavlin Distributing Company · 2011
- Descendant · cites it directly · 0 of its ownK151795 ML24000 UVA-1 Phototherapy CabinetDaavlin Distributing Co. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151795ML24000 UVA-1 Phototherapy CabinetDaavlin Distributing Co. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041212 | Houva 3 Phototherapy System | National Biological Corp. | 2004 | 1 |
| 0 (this device) | K103708 | ML24000 Uva-1 Phototherapy Unit | The Daavlin Distributing Company | 2011 | — |
| +1 | K151795 | ML24000 UVA-1 Phototherapy Cabinet | Daavlin Distributing Co. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010378 | FDA’s K010378 is Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ Our reading of the summary gave K010378, FDA’s number for Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZ (Implex Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Daavlin Distributing Company 1 Series Phototherapy Cabinet…”. Kept off the family tree. | 2002 |
| * | K041212 | Houva 3 Phototherapy SystemSummary page 2…Houva Ill Phototherapy System With PhotoSense 11Exposure Control K041212 Device Description: The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with… | 2004 |
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 |
|---|---|---|---|
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | 2015 | 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?
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103708: ML24000 Uva-1 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/K103708
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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