510(k) · Cleared
Recalled · Class II · 20224 Series Phototherapy Unit Model 4 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daavlin Distributing Co. · FTC Light, Ultraviolet, Dermatological
Cleared on Aug 29, 2011 as substantially equivalent to K100378 (Daavlin Distributing Co., 2010) after a 125-day review. Its family tree reaches back 3 generations to 1983. It has been recalled once.
- Decided
- Aug 29, 2011
- Review
- 125 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K828654 (1983). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 2 generations backK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- 1 generation backK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- This deviceK111172 4 Series Phototherapy Unit Model 4 SeriesDaavlin Distributing Co. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| −2 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| −1 | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | 1 |
| 0 (this device) | K111172 | 4 Series Phototherapy Unit Model 4 Series | Daavlin Distributing Co. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Summary page 1…skin disorders Predicate Device: Daavliri Distributing Company 1 Series Phototherapy Unit K1 00378 Device Description: The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2022 | Class II | Z-1074-2022 | Software Design Change | Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K100378.
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 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111172: 4 Series Phototherapy Unit Model 4 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111172
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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