510(k) · Cleared
ClearedHouva-NET Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Biological Corporation · FTC Light, Ultraviolet, Dermatological
Cleared on Jul 10, 2015 as substantially equivalent to K041212 (National Biological Corp., 2004) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jul 10, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K828654 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK828654 Uvb Cabinet or Goekerman Cabinet, Model Spectra 305Daavlin Co. · 1983
- 2 generations backK063621 3 Series Phototherapy CabinetDaavlin Co. · 2007
- 1 generation backK110912 Smart Touch Uvtherapy Multiple MachineDaavlin Distributing Co. · 2011
- This deviceK150912 Houva-NET Control SystemNational Biological Corporation · 2015
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 | K063621 | 3 Series Phototherapy Cabinet | Daavlin Co. | 2007 | — |
| −1 | K110912 | Smart Touch Uvtherapy Multiple Machine | Daavlin Distributing Co. | 2011 | — |
| 0 (this device) | K150912 | Houva-NET Control System | National Biological Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K041212 | Houva 3 Phototherapy SystemSummary page 4…General and Plastic Surgery Class II Equivalent legally marketed devices: Houva III Phototherapy System with PhotoSense IITM (K041212) Houva V with Houva-NET Control System – Traditional 510(k) 510(k) Summary… | 2004 |
| * | K110912 | Smart Touch Uvtherapy Multiple MachineSummary page 5…of 5 K150912 The Daavlin Smart Touch Multi-Machine Software (K110912) provides an example of a cleared device considering a single control board managing multiple phototherapy devices via a single c… | 2011 |
| † | K885025 | Houva II Uva | 1989 |
| † | K885026 | Houva II Uvb | 1989 |
| † | K885029 | Houva II Uva/Uvb | 1989 |
| † | K063621 | 3 Series Phototherapy Cabinet | 2007 |
| † | K042502 | 3 Series Phototherapy Cabinet | 2004 |
| † | K828654 | Uvb Cabinet or Goekerman Cabinet, Model Spectra 305 | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K041212.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Houva-NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis and vitiligo.
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/K150912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150912: Houva-NET Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150912
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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