510(k) · Cleared
Recalled · Class II · 2026M Series Phototherapy Equipment
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 Jun 22, 2021 as substantially equivalent to K182215 (Daavlin Distributing Company, 2018) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1983. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 22, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K828654 (1983). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 3 generations backK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- 2 generations backK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- 1 generation backK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- This deviceK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021
- 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 |
|---|---|---|---|---|---|
| −4 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| −3 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| −2 | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | 1 |
| −1 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| 0 (this device) | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | — |
| +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 | — |
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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182215 | ClearLink Controlled Phototherapy EquipmentSummary page 5…ss I Product Code: FTC Panel: General and Plastic Surgery Predicate Devices: ClearLink Contrglled Phototherapy Equipment & 1 Series Phototherapy Unit 510(k) Numbers: K182215 & K100378 Product Code: FTC Company: Daavlin Distributing Company Device Description: The M Series Phototherapy Devices are i… | 2018 |
| * | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Summary page 5…uct Code: FTC Panel: General and Plastic Surgery Predicate Devices: ClearLink Contrglled Phototherapy Equipment & 1 Series Phototherapy Unit 510(k) Numbers: K182215 & K100378 Product Code: FTC Company: Daavlin Distributing Company Device Description: The M Series Phototherapy Devices are intended to… | 2010 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-2742-2026 | Software Design Change | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K230382 (Daavlin Distributing Co., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K182215.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.
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/K210881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210881: M Series Phototherapy Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210881
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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