510(k) · Cleared
ClearedPsoria-Shield AURORA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psoria-Shield · FTC Light, Ultraviolet, Dermatological
Cleared on Jul 2, 2020 as substantially equivalent to K103540 (Psoria-Shield, Inc., 2011) after a 302-day review. Its family tree reaches back 7 generations to 1989. 2 later devices descend from it.
- Decided
- Jul 2, 2020
- Review
- 302 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K885026 (1989). 17 ancestors in all, the oldest K885025 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 6 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 5 generations backK020847 Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002
- 4 generations backK031451 Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc. · 2003
- 3 generations backK041943 Xtrac XL, Model AL8000Photo Medex, Inc. · 2004
- 2 generations backK073659 Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008
- 1 generation backK103540 Psoria-LightPsoria-Shield, Inc. · 2011
- This deviceK192411 Psoria-Shield AURORAPsoria-Shield · 2020
- Descendant · cites it directly · 0 of its ownK254234 Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230076 Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −6 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −5 | K020847 | Xtrac Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2002 | — |
| −4 | K031451 | Xtracxl Plus Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2003 | — |
| −3 | K041943 | Xtrac XL, Model AL8000 | Photo Medex, Inc. | 2004 | — |
| −2 | K073659 | Xtrac Ultra 2, Model AL10000 | Photo Medex, Inc. | 2008 | — |
| −1 | K103540 | Psoria-Light | Psoria-Shield, Inc. | 2011 | — |
| 0 (this device) | K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020 | — |
| +1 | K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | 2026 | — |
| +1 | K230076 | Enhanced AURORA™ Medical Diode System, and related accessories | Psoria-Shield, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K103540 | Psoria-LightSummary page 4…: Ultraviolet lamp for dermatologic disorders Classification Name: Light, Ultraviolet, Dermatological Predicate Device Psoria-Shield Inc’s PS1000 (K103540, cleared 2011) Purpose of the Special 510(k) Notice The AURORA is a modification to Psoria-Shield’s existing PS1000 sy… | 2011 |
What descends from it? (2)
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)
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 31 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K254234 (Choyang Medics Co., Ltd., 2026) has gone furthest, with 0 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. 2020, 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 AURORA system is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192411: Psoria-Shield AURORA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192411
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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