510(k) · Cleared
Recalled · 2008Houva 3 Phototherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Biological Corp. · FTC Light, Ultraviolet, Dermatological
Cleared on Jun 9, 2004 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 55 later devices descend from it. It has been recalled once.
- Decided
- Jun 9, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- FTC
- Recalls
- 1
- Predicates
- 0
55 later devices descend from it, 4 citing it directly.
- This deviceK041212 Houva 3 Phototherapy SystemNational Biological Corp. · 2004
- Descendant · cites it directly · 47 of its ownK051259 Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005
- Descendant · 2 generations on · 46 of its ownK090762 LEDAQuantel Derma GmbH · 2009
- Descendant · 3 generations on · 24 of its ownK200104 OxylightRaja Trading Company, Inc. · 2020
- Descendant · 4 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 4 generations on · 11 of its ownK222751 LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K051259Versaclear Skin Therapy System, Model 100Theralight, Inc. · 2005 · cites it directly47descendants
- K090762LEDAQuantel Derma GmbH · 2009 · 2 generations on46descendants
- K200104OxylightRaja Trading Company, Inc. · 2020 · 3 generations on24descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 4 generations on16descendants
- K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd. · 2023 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041212 | Houva 3 Phototherapy System | National Biological Corp. | 2004 | — |
| +1 | K051259 | Versaclear Skin Therapy System, Model 100 | Theralight, Inc. | 2005 | — |
| +2 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| +3 | K200104 | Oxylight | Raja Trading Company, Inc. | 2020 | — |
| +4 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +4 | K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (55)
See all 554 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 |
|---|---|---|---|---|
| Feb 19, 2008 | Not classified | Z-1309-2008 | Software design | Software allows operator to override "low line voltage" error warning and store light intensity value. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051259 (Theralight, Inc., 2005) has gone furthest, with 47 descendants of its own.
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 I IOUVA 3 Phototherapy system with PhotoSense [ITM Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041212: Houva 3 Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041212
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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