510(k) · Cleared
Recalled · Class II · 20221 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4
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 Apr 28, 2010 as substantially equivalent to K073587 (Daavlin Distributing Co., 2008) and 3 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1983. 6 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K828654 (1983). 7 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 1 generation backK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- This deviceK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010
- Descendant · cites it directly · 4 of its ownK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
- 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 ownK212510 7 Series Phototherapy DeviceDaavlin Distributing Co. · 2021 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · cites it directly4descendants
- K210881M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · cites it directly2descendants
- K2303823 Series NeoLuxDaavlin Distributing Co. · 2023 · 2 generations on1descendant
- K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
- K2125107 Series Phototherapy DeviceDaavlin Distributing Co. · 2021 · 2 generations on0descendants
View 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 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| 0 (this device) | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | — |
| +1 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| +1 | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | 1 |
| +2 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
| +3 | K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K073587 | Dermapal with Digital TimerSummary page 2…== 14667/ Predicate Device: Daavlin Distributing Company Digital DermaPaIl' K073587 Daavlin Distributing Company Flex Controlled Phototherapy Equi… | 2008 |
| * | K050695 | Flex Controlled Phototherapy EquipmentSummary page 2…7 Daavlin Distributing Company Flex Controlled Phototherapy Equipment K050695 National Biological Corporation Panosol Tru-Blu Phototherapy S… | 2005 |
| * | K070934 | Panosol II Tru-Blu, Model Ubl-417Summary page 2…5 National Biological Corporation Panosol Tru-Blu Phototherapy System *K070934 DUSA Pharmaceuticals, Inc. BLU-U, MODEL 4170… | 2007 |
| * | K031805 | Blu-U, Model 4170Summary page 2…*K070934 DUSA Pharmaceuticals, Inc. BLU-U, MODEL 4170 K031 805 1•(a371 Device Description: The 1 Series Unit is a partial-body phototherapy panel u… | 2003 |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2022 | Class II | Z-1073-2022 | 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 27 years and passes through 2 companies; a new generation was cleared every 22.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K182215 (Daavlin Distributing Company, 2018) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K073587.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L-36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100378: 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100378
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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