510(k) · Cleared
Cleared308nm Excimer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Peninsula Medical Technology Co., Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on May 13, 2020 as substantially equivalent to K173436 (Luma Therapeutics, 2018) and 2 other predicates after a 232-day review. Its family tree reaches back 19 generations to 1995. 2 later devices descend from it.
- Decided
- May 13, 2020
- Review
- 232 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K943450 (1995). 248 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 2 generations backK171702 Exciplex308nmClarteis · 2017
- 1 generation backK191086 ExciplexClarteis · 2019
- This deviceK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK200971 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK242977 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 4 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 3 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 2 generations backK171702 Exciplex308nmClarteis · 2017
- 1 generation backK191086 ExciplexClarteis · 2019
- This deviceK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −4 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| −3 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
| −2 | K171702 | Exciplex308nm | Clarteis | 2017 | — |
| −1 | K191086 | Exciplex | Clarteis | 2019 | — |
| 0 (this device) | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +1 | K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
| +2 | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 21 | 0 |
| 1998 | 12 | 0 |
| 1999 | 9 | 0 |
| 2000 | 19 | 0 |
| 2001 | 22 | 0 |
| 2002 | 31 | 0 |
| 2003 | 18 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K173436 | Luma Light SystemSummary page 4…orders Review Panel: Dermatology, Physical Medicine Product Code: FTC Regulation Class: II Regulation Number: 878.4630 3. Predicate Device Information 1 510(K) Number: K173436 Company Name: Luma Therapeutics Trade/Device Name: Luma Light System Common Name: Light, Ultraviolet, Dermatological Regulation N… | 2018 |
| * | K172273 | 308nm Excimer SystemSummary page 4…s such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). Predicate Device Information 2 510(K) Number: K172273 Company Name: Chongqing Peninsula Medical Technology Co., Ltd.… | 2018 |
| * | K191086 | Exciplex Cleared while this submission was under review Summary page 5…m Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only. Predicate Device Information 3 510(K) Number: K191086 Company Name: Clarteis Trade/Device Name: Exciplex Common Name: Light, Ultraviolet, Dermatological Regulation Number: 878.4630 Re… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200971 | 308nm Excimer System | 2020 | 1 |
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 25 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 11 of the 248 ancestors have a recall of any class.
- Of its descendants, K200971 (Xuzhou Kernel Medical Equipment Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192642: 308nm Excimer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192642
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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