510(k) · Cleared
ClearedPastelle Q-Switched ND: Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Won Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 11, 2013 as substantially equivalent to K014234 (Continuum Electro-Optics, Inc., 2002) and 2 other predicates after a 171-day review. Its family tree reaches back 16 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 11, 2013
- Review
- 171 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 250 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- This deviceK123293 Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK202288 FinebeamSNJ Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK260256 Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250165 PastelleWontech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250936 Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd · 2025
- Descendant · 2 generations on · 0 of its ownK243780 HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 1 generation backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- This deviceK123293 Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd. · 2013
Most influential descendants
Showing 5 of 5 · See all- K202288FinebeamSNJ Co., Ltd. · 2021 · cites it directly2descendants
- K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K250165PastelleWontech Co., Ltd. · 2025 · cites it directly0descendants
- K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd · 2025 · cites it directly0descendants
- K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −1 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| 0 (this device) | K123293 | Pastelle Q-Switched ND: Yag Laser | Won Technology Co., Ltd. | 2013 | — |
| +1 | K202288 | Finebeam | SNJ Co., Ltd. | 2021 | — |
| +2 | K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026 | — |
| +1 | K250165 | Pastelle | Wontech Co., Ltd. | 2025 | — |
| +1 | K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2025 | — |
| +2 | K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 22 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 22 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 3…WONellTechnology Optics, Inc. MedLite Nd:YAG Laser K123293 Q-Switched Nd:YAG Laser K014234 Laser Type 0-Switched Nd:YAG 0-Switched Nd:YAG Wavelength 532nm, 1064nm… | 2002 |
| * | K080248 | Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye HandpiecesSummary page 2…. Predicate Device: MedLite C6 0-Switched Nd:YAG Laser (KOl 4234) Lutronic Spectra VRMffl(K080248) HOYA Conbio RevLite Q-Switched Nd: YAG Laaser System (K083899) 10. Descript… | 2008 |
| * | K083899 | Revlite Q-Switched ND:Yag Laser SystemSummary page 2…=== Lutronic Spectra VRMffl(K080248) HOYA Conbio RevLite Q-Switched Nd: YAG Laaser System (K083899) 10. Description of the The WON Technology's Pastelle Q-Switched Nd:YAG WON Technology Laser uses a Nd:YAG materia… | 2009 |
What descends from it? (5)
3 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 18 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 9 of the 250 ancestors have a recall of any class.
- Of its descendants, K202288 (SNJ Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K014234.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the
Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology,
Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123293: Pastelle Q-Switched ND: Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123293
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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