510(k) · Cleared
ClearedEnhanced AURORA™ Medical Diode System, and related accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psoria-Shield, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Mar 8, 2023 as substantially equivalent to K192411 (Psoria-Shield, 2020) and 1 other predicate after a 57-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Mar 8, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K885026 (1989). 18 ancestors in all, the oldest K885025 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 7 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 6 generations backK020847 Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002
- 5 generations backK031451 Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc. · 2003
- 4 generations backK041943 Xtrac XL, Model AL8000Photo Medex, Inc. · 2004
- 3 generations backK073659 Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008
- 2 generations backK103540 Psoria-LightPsoria-Shield, Inc. · 2011
- 1 generation backK192411 Psoria-Shield AURORAPsoria-Shield · 2020
- This deviceK230076 Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −7 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −6 | K020847 | Xtrac Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2002 | — |
| −5 | K031451 | Xtracxl Plus Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2003 | — |
| −4 | K041943 | Xtrac XL, Model AL8000 | Photo Medex, Inc. | 2004 | — |
| −3 | K073659 | Xtrac Ultra 2, Model AL10000 | Photo Medex, Inc. | 2008 | — |
| −2 | K103540 | Psoria-Light | Psoria-Shield, Inc. | 2011 | — |
| −1 | K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192411 | Psoria-Shield AURORASummary page 5…AURORA™ system, and related accessories Establishment Registration Number: 3008872264 Predicate Devices: The Psoria-Shield, Inc. AURORA™ (K192411 July 2, 2020) The PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model… | 2020 |
| * | K073659 | Xtrac Ultra 2, Model AL10000Summary page 5…-Shield, Inc. AURORA™ (K192411 July 2, 2020) The PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000 (K073659 January 2, 2008). Purpose of this Submission: Psoria-Shield is seeking to introduce the Enhanced AURORA TM… | 2008 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K192411.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Enhanced AURORA™ Medical Diode system and related accessories 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/K230076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230076: Enhanced AURORA™ Medical Diode System, and related accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230076
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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