510(k) · Cleared
Recalled · Class II · 20267 Series Phototherapy Device
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 Nov 4, 2021 as substantially equivalent to K182215 (Daavlin Distributing Company, 2018) after an 86-day review. Its family tree reaches back 4 generations to 1983. It has been recalled once.
- Decided
- Nov 4, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K828654 (1983). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK212510 7 Series Phototherapy DeviceDaavlin Distributing Co. · 2021
View 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) | K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021 | — |
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 |
|---|---|---|---|
| * | K182215 | ClearLink Controlled Phototherapy EquipmentSummary page 4…Class II Product Code: FTC Panel: General and Plastic Surgery Predicate Devices: ClearLink Phototherapy Equipment 510(k) Numbers: K182215 Product Code: FTC Company: Daavlin Distributing Company The 7 Series Phototherap… | 2018 |
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 |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-2743-2026 | 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.
- 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 7 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 population may range from pediatric 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/K212510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212510: 7 Series Phototherapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212510
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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