510(k) · Cleared
ClearedXtrac Ultra 2, Model AL10000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photo Medex, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 5, 2008 as substantially equivalent to K992914 (Acculase, Inc., 2000) and 5 other predicates after a 70-day review. Its family tree reaches back 5 generations to 1989. 7 later devices descend from it.
- Decided
- Mar 5, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K885026 (1989). 10 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 4 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 3 generations backK020847 Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002
- 2 generations backK031451 Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc. · 2003
- 1 generation backK041943 Xtrac XL, Model AL8000Photo Medex, Inc. · 2004
- This deviceK073659 Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK103540 Psoria-LightPsoria-Shield, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK192411 Psoria-Shield AURORAPsoria-Shield · 2020
- Descendant · cites it directly · 1 of its ownK193478 XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc. · 2020
- Descendant · 3 generations on · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103540Psoria-LightPsoria-Shield, Inc. · 2011 · cites it directly3descendants
- K192411Psoria-Shield AURORAPsoria-Shield · 2020 · 2 generations on2descendants
- K193478XTRAC Momentum Excimer Laser SystemStrata Skin Sciences, Inc. · 2020 · cites it directly1descendant
- K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd. · 2026 · 3 generations on0descendants
- K230076Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −4 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −3 | K020847 | Xtrac Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2002 | — |
| −2 | K031451 | Xtracxl Plus Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2003 | — |
| −1 | K041943 | Xtrac XL, Model AL8000 | Photo Medex, Inc. | 2004 | — |
| 0 (this device) | K073659 | Xtrac Ultra 2, Model AL10000 | Photo Medex, Inc. | 2008 | — |
| +1 | K103540 | Psoria-Light | Psoria-Shield, Inc. | 2011 | — |
| +2 | K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020 | — |
| +1 | K193478 | XTRAC Momentum Excimer Laser System | Strata Skin Sciences, Inc. | 2020 | — |
| +3 | 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 |
|---|---|---|
| 1993 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K992914 | Excimer Laser Phototherapy System, AL7000Summary page 1…System, Model ALlOOOO0 3. PREDICATE DEVICES Excimer Laser * Excimer Laser Phototherapy System, model AL7000, AccuLase (PhotoMedex), cleared via 5 10(k) K992914 * XTRAC Exejiner Laser System. Model AL7000, PhotoMedex, Inc., cleared via 510(k) K003705 * XTRAC Excimner La… | 2000 |
| * | K003705 | Xtrac Excimer Laser System, Model AL7000Summary page 1…model AL7000, AccuLase (PhotoMedex), cleared via 5 10(k) K992914 * XTRAC Exejiner Laser System. Model AL7000, PhotoMedex, Inc., cleared via 510(k) K003705 * XTRAC Excimner Laser System. Model AL7000, PhotoMedex, hinc., cleared via 510(k) K01 1382 * XTRAC Excimer L… | 2001 |
| * | K011382 | Xtrac Excimer Laser System, Model AL 7000Summary page 1…stem. Model AL7000, PhotoMedex, Inc., cleared via 510(k) K003705 * XTRAC Excimner Laser System. Model AL7000, PhotoMedex, hinc., cleared via 510(k) K01 1382 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL Plus Exc… | 2001 |
| * | K020847 | Xtrac Excimer Laser System, Model AL7000Summary page 1…tem. Model AL7000, PhotoMedex, hinc., cleared via 510(k) K01 1382 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. cleared via 5 10O(k) K031451 * XTRAC XL2(n… | 2002 |
| * | K031451 | Xtracxl Plus Excimer Laser System, Model AL7000Summary page 1…del AL7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. cleared via 5 10O(k) K031451 * XTRAC XL2(now known as the XTRAC Ultra) Excimer Laser System, Model AL8000, PhotoMedex, Inc. cleared via 5 10(k) K041… | 2003 |
| * | K041943 | Xtrac XL, Model AL8000Summary page 1…x, Inc. cleared via 5 10O(k) K031451 * XTRAC XL2(now known as the XTRAC Ultra) Excimer Laser System, Model AL8000, PhotoMedex, Inc. cleared via 5 10(k) K041 943 XIX-2 PhotoMedex, 510(k) Suiiinary XTRAC Ultra 2 Excinier Laser, Model… | 2004 |
What descends from it? (7)
4 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 19 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K103540 (Psoria-Shield, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K992914.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073659: Xtrac Ultra 2, Model AL10000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073659
Report an extraction error
Are you the manufacturer?
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