510(k) · Cleared
ClearedHouva II Uva
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 Jan 9, 1989 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 333 later devices descend from it.
- Decided
- Jan 9, 1989
- Review
- 35 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
333 later devices descend from it, 2 citing it directly.
- This deviceK885025 Houva II UvaNational Biological Corp. · 1989
- Descendant · cites it directly · 291 of its ownK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- Descendant · 2 generations on · 289 of its ownK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- Descendant · 2 generations on · 280 of its ownK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- Descendant · 2 generations on · 274 of its ownK051428 Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Showing 5 of 333 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 333 · See all- K022165Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002 · cites it directly291descendants
- K024020Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003 · 2 generations on289descendants
- K040062Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004 · 2 generations on280descendants
- K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005 · 2 generations on274descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885025 | Houva II Uva | National Biological Corp. | 1989 | — |
| +1 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| +2 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| +2 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| +2 | K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | 2005 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 14 | 0 |
| 2016 | 15 | 0 |
| 2017 | 21 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 27 | 0 |
| 2021 | 18 | 0 |
| 2022 | 27 | 0 |
| 2023 | 23 | 0 |
| 2024 | 37 | 0 |
| 2025 | 45 | 0 |
| 2026 | 29 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (333)
See all 3332 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022165 (Theralight, Inc., 2002) has gone furthest, with 291 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 | — |
https://510kreport.com/device/K885025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K885025: Houva II Uva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885025
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026