510(k) · Cleared
ClearedExciplex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarteis · FTC Light, Ultraviolet, Dermatological
Cleared on Dec 11, 2019 as substantially equivalent to K171702 (Clarteis, 2017) after a 231-day review. Its family tree reaches back 18 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 11, 2019
- Review
- 231 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K943450 (1995). 233 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 2 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 1 generation backK171702 Exciplex308nmClarteis · 2017
- This deviceK191086 ExciplexClarteis · 2019
- Descendant · cites it directly · 2 of its ownK192642 308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK200971 308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK242977 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK221623 FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm…Gme German Medical Engineering GmbH · 2023
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 3 generations backK090762 LEDAQuantel Derma GmbH · 2009
- 2 generations backK150752 GME ExSys 308Gme (German Medical Engineering) GmbH · 2015
- 1 generation backK171702 Exciplex308nmClarteis · 2017
- This deviceK191086 ExciplexClarteis · 2019
Most influential descendants
Showing 4 of 4 · See all- K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. · 2020 · cites it directly2descendants
- K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2020 · 2 generations on1descendant
- K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd. · 2025 · 3 generations on0descendants
- K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −3 | K090762 | LEDA | Quantel Derma GmbH | 2009 | — |
| −2 | K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015 | — |
| −1 | K171702 | Exciplex308nm | Clarteis | 2017 | — |
| 0 (this device) | K191086 | Exciplex | Clarteis | 2019 | — |
| +1 | K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020 | — |
| +2 | K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020 | — |
| +3 | K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C… | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025 | — |
| +1 | K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm | Gme German Medical Engineering GmbH | 2023 | — |
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 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 10 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 21 | 0 |
| 1998 | 12 | 0 |
| 1999 | 8 | 0 |
| 2000 | 19 | 0 |
| 2001 | 22 | 0 |
| 2002 | 29 | 0 |
| 2003 | 18 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171702 | Exciplex308nmSummary page 4…ATION The Exciplex is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K171702 Exciplex308nm/ Clarteis The predicate device has not been subject to a des… | 2017 |
What descends from it? (4)
2 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 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 233 ancestors have a recall of any class.
- Of its descendants, K192642 (Chongqing Peninsula Medical Technology Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K171702.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 exciplex® is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191086: Exciplex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191086
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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