510(k) · Cleared
Recalled · Class II · 2026ClearLink Controlled Phototherapy Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daavlin Distributing Company · FTC Light, Ultraviolet, Dermatological
Cleared on Oct 29, 2018 as substantially equivalent to K050695 (Daavlin Distributing Co., 2005) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 1983. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 29, 2018
- Review
- 75 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K828654 (1983). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 deviceK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018
- 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 · cites it directly · 0 of its ownK212510 7 Series Phototherapy DeviceDaavlin Distributing Co. · 2021 · Recalled
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
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) | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | — |
| +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 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050695 | Flex Controlled Phototherapy EquipmentSummary page 4…FTC Panel: General and Plastic Surgery Predicate Devices: Flex Controlled Phototherapy Equipment & 1 Series 510(k) Numbers: K050695 & K100378 Product Code: FTC Company: Daavlin Distributing Company QUAL0127 REV 1 10/2018 === Pa… | 2005 |
| * | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Summary page 4…FTC Panel: General and Plastic Surgery Predicate Devices: Flex Controlled Phototherapy Equipment & 1 Series 510(k) Numbers: K050695 & K100378 Product Code: FTC Company: Daavlin Distributing Company QUAL0127 REV 1 10/2018 D… | 2010 |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-2744-2026 | 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 35 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K210881 (Daavlin Distributing Co., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K050695.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182215: ClearLink Controlled 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/K182215
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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