510(k) · Cleared
ClearedXtrac Excimer Laser System, Model AL7000
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 May 16, 2002 as substantially equivalent to K885026 (National Biological Corp., 1989) and 5 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1989. 295 later devices descend from it.
- Decided
- May 16, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K885026 (1989). 7 ancestors in all. 295 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 1 generation backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- This deviceK020847 Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002
- Descendant · cites it directly · 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
- Descendant · 4 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Showing 5 of 295 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 295 · See all- K024020Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003 · cites it directly289descendants
- 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
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 4 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −1 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| 0 (this device) | K020847 | Xtrac Excimer Laser System, Model AL7000 | Photo Medex, Inc. | 2002 | — |
| +1 | 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 | — |
| +4 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
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 |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 20 | 0 |
| 2018 | 18 | 0 |
| 2019 | 12 | 0 |
| 2020 | 26 | 0 |
| 2021 | 17 | 0 |
| 2022 | 26 | 0 |
| 2023 | 21 | 0 |
| 2024 | 32 | 0 |
| 2025 | 31 | 0 |
| 2026 | 25 | 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 |
|---|---|---|---|
| * | K885026 | Houva II UvbSummary page 1…imer Laser System, model AL7000 3. PREDICATE DEVICES Ultraviolet Phototherapy Systems — HOUVA II, Phototherapy System, National Biological Corporation, 510(k) number: K885026 - UviSol, Phototherapy System, National Biological Corporation, 510(k) number: K934808 DermaClear UV-B Phototherapy System, Coher… | 1989 |
| * | K934808 | Uvisol and Uvisol IISummary page 1…— HOUVA II, Phototherapy System, National Biological Corporation, 510(k) number: K885026 - UviSol, Phototherapy System, National Biological Corporation, 510(k) number: K934808 DermaClear UV-B Phototherapy System, Coherent Star/Lumenis 510(k) number K011197 Excimer Laser — XTRAC Excimer Laser System, mod… | 1993 |
| * | K011197 | Dermaclear UV-B Phototherapy SystemSummary page 1…: K885026 - UviSol, Phototherapy System, National Biological Corporation, 510(k) number: K934808 DermaClear UV-B Phototherapy System, Coherent Star/Lumenis 510(k) number K011197 Excimer Laser — XTRAC Excimer Laser System, model AL7000, PhotoMedex, Inc., 510(k) numbers: K992914, K003705, and K011382 XVI-2… | 2001 |
| * | K992914 | Excimer Laser Phototherapy System, AL7000Summary page 1…aClear UV-B Phototherapy System, Coherent Star/Lumenis 510(k) number K011197 Excimer Laser — XTRAC Excimer Laser System, model AL7000, PhotoMedex, Inc., 510(k) numbers: K992914, K003705, and K011382 XVI-2 510 (k) Summary Fopr29) 23 XTRAC Excimer Laser 4. DEVICE DESCRIPTION The XTRAC Ex… | 2000 |
| * | K003705 | Xtrac Excimer Laser System, Model AL7000Summary page 1…-B Phototherapy System, Coherent Star/Lumenis 510(k) number K011197 Excimer Laser — XTRAC Excimer Laser System, model AL7000, PhotoMedex, Inc., 510(k) numbers: K992914, K003705, and K011382 XVI-2 510 (k) Summary Fopr29) 23 XTRAC Excimer Laser 4. DEVICE DESCRIPTION The XTRAC Excimer Las… | 2001 |
| * | K011382 | Xtrac Excimer Laser System, Model AL 7000Summary page 1…py System, Coherent Star/Lumenis 510(k) number K011197 Excimer Laser — XTRAC Excimer Laser System, model AL7000, PhotoMedex, Inc., 510(k) numbers: K992914, K003705, and K011382 XVI-2 510 (k) Summary Fopr29) 23 XTRAC Excimer Laser 4. DEVICE DESCRIPTION The XTRAC Excimer Laser System is… | 2001 |
What descends from it? (295)
See all 2956 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | 2003 | 289 |
| K031451 | Xtracxl Plus Excimer Laser System, Model AL7000 | 2003 | 12 |
| K041943 | Xtrac XL, Model AL8000 | 2004 | 11 |
| K073659 | Xtrac Ultra 2, Model AL10000 | 2008 | 7 |
| K062963 | Pharos Excimer Laser System, Model EX-308 | 2007 | 3 |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | 2017 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K024020 (Theralight, Inc., 2003) has gone furthest, with 289 descendants of its own.
- 2 other devices also cite its predicate K885026.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020847: Xtrac Excimer Laser System, Model AL7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020847
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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