510(k) · Cleared
Cleared308 Dermatological Excimer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Dec 26, 2007 as substantially equivalent to K051428 (Photo Medex, Inc., 2005) after a 57-day review. Its family tree reaches back 7 generations to 1989. 6 later devices descend from it.
- Decided
- Dec 26, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K885026 (1989). 18 ancestors in all, the oldest K885025 (1989). 6 later devices descend from it, 1 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 backK020591 BclearLumenis · 2002
- 4 generations backK022165 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc. · 2002
- 3 generations backK024020 Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc. · 2003
- 2 generations backK040062 Levia Phototherapy SystemLerner Medical Devices, Inc. · 2004
- 1 generation backK051428 Vtrac Excimer Lamp SystemPhoto Medex, Inc. · 2005
- This deviceK073066 308 Dermatological Excimer SystemQuantel Medical, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK171702 Exciplex308nmClarteis · 2017
- Descendant · 2 generations on · 4 of its ownK191086 ExciplexClarteis · 2019
- Descendant · 3 generations on · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK200971 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
- Descendant · 5 generations on · 0 of its ownK242977 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171702Exciplex308nmClarteis · 2017 · cites it directly5descendants
- K191086ExciplexClarteis · 2019 · 2 generations on4descendants
- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · 3 generations on2descendants
- K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020 · 4 generations on1descendant
- K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025 · 5 generations on0descendants
View 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 | K020591 | Bclear | Lumenis | 2002 | — |
| −4 | K022165 | Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 | Theralight, Inc. | 2002 | — |
| −3 | K024020 | Theralight UV120-2 Uva/Uvb Phototherapy System | Theralight, Inc. | 2003 | — |
| −2 | K040062 | Levia Phototherapy System | Lerner Medical Devices, Inc. | 2004 | — |
| −1 | K051428 | Vtrac Excimer Lamp System | Photo Medex, Inc. | 2005 | — |
| 0 (this device) | K073066 | 308 Dermatological Excimer System | Quantel Medical, Inc. | 2007 | — |
| +1 | K171702 | Exciplex308nm | Clarteis | 2017 | — |
| +2 | K191086 | Exciplex | Clarteis | 2019 | — |
| +3 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +4 | K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
| +5 | K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C… | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K051428 | Vtrac Excimer Lamp SystemSummary page 1…xcimer Lamp Phototherapy system Classification name: Ultraviolet Lamp for Dermatological Disorders (3) Equivalent legally-marketed devices. PhotoMedex VTRAC XL, K051428 (4) Description The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a x… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171702 | Exciplex308nm | 2017 | 5 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K171702 (Clarteis, 2017) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K051428.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073066: 308 Dermatological Excimer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073066
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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