510(k) · Cleared
ClearedVtrac Excimer Lamp System
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 Aug 9, 2005 as substantially equivalent to K024020 (Theralight, Inc., 2003) and 4 other predicates after a 69-day review. Its family tree reaches back 6 generations to 1989. 274 later devices descend from it.
- Decided
- Aug 9, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K885026 (1989). 17 ancestors in all, the oldest K885025 (1989). 274 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 5 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 4 generations backK020591 BclearLumenis · 2002
- 3 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 2 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 1 generation backK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- This deviceK051428 Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 87 of its ownK121346 Picosure WorkstationCynosure, Inc. · 2012
Showing 5 of 274 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 274 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants
- K121346Picosure WorkstationCynosure, Inc. · 2012 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −5 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −4 | K020591 | Bclear | Lumenis | 2002 | — |
| −3 | 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 | — |
| −1 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| 0 (this device) | K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | 2005 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| +4 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 18 | 0 |
| 2018 | 16 | 0 |
| 2019 | 12 | 0 |
| 2020 | 23 | 0 |
| 2021 | 17 | 0 |
| 2022 | 26 | 0 |
| 2023 | 19 | 0 |
| 2024 | 32 | 0 |
| 2025 | 31 | 0 |
| 2026 | 23 | 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? (5)
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 |
|---|---|---|---|
| * | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy SystemSummary page 1…proprietary name: VIRAC Excimer Lamp System 3. LEGALLY MARKETED PREDICATE DEVICES TheraLight UV120-2 UVA/IUVB Phototherapy System Cleared via K024020 and K022 165 Lumenis BClearTm Cleared via K020591 and K02 1762 Levia Phototherapy System… | 2003 |
| * | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Summary page 1…name: VIRAC Excimer Lamp System 3. LEGALLY MARKETED PREDICATE DEVICES TheraLight UV120-2 UVA/IUVB Phototherapy System Cleared via K024020 and K022 165 Lumenis BClearTm Cleared via K020591 and K02 1762 Levia Phototherapy System C… | 2002 |
| * | K020591 | BclearSummary page 1…E DEVICES TheraLight UV120-2 UVA/IUVB Phototherapy System Cleared via K024020 and K022 165 Lumenis BClearTm Cleared via K020591 and K02 1762 Levia Phototherapy System Cleared via K040062 4. DEVICE DESCRIPTION The VTRAC Exc… | 2002 |
| * | K021762 | BclearSummary page 1…TheraLight UV120-2 UVA/IUVB Phototherapy System Cleared via K024020 and K022 165 Lumenis BClearTm Cleared via K020591 and K02 1762 Levia Phototherapy System Cleared via K040062 4. DEVICE DESCRIPTION The VTRAC Excimer Lamp Sys… | 2002 |
| * | K040062 | Levia Phototherapy SystemSummary page 1…ared via K024020 and K022 165 Lumenis BClearTm Cleared via K020591 and K02 1762 Levia Phototherapy System Cleared via K040062 4. DEVICE DESCRIPTION The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) dermatological p… | 2004 |
What descends from it? (274)
See all 2743 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 16 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants of its own.
- 5 other devices also cite its predicate K024020.
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 skin conditions which include psoriasis, vitiligo, atopic dermatitis and leukoderma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051428: Vtrac Excimer Lamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051428
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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