510(k) · Cleared
ClearedFlex Controlled 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 Apr 19, 2005 as substantially equivalent to K828654 (Daavlin Co., 1983) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 1983. 12 later devices descend from it.
- Decided
- Apr 19, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K828654 (1983). 2 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- This deviceK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- Descendant · cites it directly · 6 of its ownK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- Descendant · cites it directly · 4 of its ownK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
- Descendant · cites it directly · 1 of its ownK111049 Mobile Versa LightMedtek Lighting Corp · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K1003781 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · cites it directly6descendants
- K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · cites it directly4descendants
- K210881M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · 2 generations on2descendants
- K2303823 Series NeoLuxDaavlin Distributing Co. · 2023 · 3 generations on1descendant
- K111049Mobile Versa LightMedtek Lighting Corp · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | Daavlin Co. | 1983 | — |
| 0 (this device) | 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 |
| +1 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| +2 | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | 1 |
| +3 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
| +1 | K111049 | Mobile Versa Light | Medtek Lighting Corp | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Summary page 1…ologic/skin disorders Predicate Device: Daavlin Distributing Company Spectra 300 Series, Ultraviolet Phototherapy Device, K828654 Spectra 724 Series, Ultraviolet Phototherapy Device, K854498 Spec… | 1983 |
| * | K854498 | Spectra 724Summary page 1…Spectra 300 Series, Ultraviolet Phototherapy Device, K828654 Spectra 724 Series, Ultraviolet Phototherapy Device, K854498 Spectra Mini Series, Ultraviolet Phototherapy Device, K820690 Device Description… | 1985 |
| Kept off the family tree | K820690 | Daavlin Distributing Company Spectra Mini Series, Ultraviolet Phototherapy… Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Spectra 724 Series, Ultraviolet Phototherapy Device, K854498 Spectra Mini Series, Ultraviolet Phototherapy Device, K820690 Device Description: The Flex controlled phototherapy equipment is a microprocessor controlled fluorescent ultrav… |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | 2010 | 6 |
| K182215 | ClearLink Controlled Phototherapy Equipment | 2018 | 4 |
| K111049 | Mobile Versa Light | 2012 | 1 |
| K091568 | LH-75 Phototherapy System | 2009 | 0 |
| K082731 | ML24000 Uva-1 Phototherapy Cabinet | 2008 | 0 |
| K061295 | Versaclear Skin Therapy System, Model 100 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Flex controlled phototherapy equipment is a medical ultraviolet device, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050695: Flex 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/K050695
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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