510(k) · Cleared
ClearedLavieen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 25, 2023 as substantially equivalent to K171009 (Lutronic Corporation, 2017) and 1 other predicate after a 255-day review. Its family tree reaches back 15 generations to 1992. 4 later devices descend from it.
- Decided
- Aug 25, 2023
- Review
- 255 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K910422 (1992). 134 ancestors in all, the oldest K820106 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations between
- 3 generations backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- 2 generations backK171009 LASEMD Laser SystemLutronic Corporation · 2017
- 1 generation backK182173 Joule SystemSciton, Inc · 2019
- This deviceK223727 LavieenWontech Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK241406 LavieenWontech Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK252732 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261589 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251919 Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 13 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 12 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 11 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 10 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 9 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 8 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 7 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 6 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 5 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 4 generations backK063808 Fraxel IV SR Laser SystemReliant Technologies, Inc. · 2007
- 3 generations backK130193 Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013
- 2 generations backK171009 LASEMD Laser SystemLutronic Corporation · 2017
- 1 generation backK182173 Joule SystemSciton, Inc · 2019
- This deviceK223727 LavieenWontech Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K241406LavieenWontech Co., Ltd. · 2024 · cites it directly2descendants
- K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −14 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −12 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −11 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −10 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −9 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −8 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −7 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −6 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −5 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −4 | K063808 | Fraxel IV SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −3 | K130193 | Fraxel Dual 1550/1927 Laser System | Solta Medical, Inc. | 2013 | — |
| −2 | K171009 | LASEMD Laser System | Lutronic Corporation | 2017 | — |
| −1 | K182173 | Joule System | Sciton, Inc | 2019 | — |
| 0 (this device) | K223727 | Lavieen | Wontech Co., Ltd. | 2023 | — |
| +1 | K241406 | Lavieen | Wontech Co., Ltd. | 2024 | — |
| +2 | K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025 | — |
| +3 | K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026 | — |
| +1 | K251919 | Thulium Laser System (Deluxlase) | Nanjing Bestview Laser S&T Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K171009 | LASEMD Laser SystemSummary page 5…) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device #1 510(k) Number: K171009 Applicant: Lutronic Corporation Classification Name: Powered Laser Surgical Instrument… | 2017 |
| * | K182173 | Joule SystemSummary page 5…ication Name: Powered Laser Surgical Instrument Trade Name: LASEMD Laser System Predicate device #2 510(k) Number: K182173 Applicant: Sciton, Inc Classification Name: Powered Laser Surgical Instrument… | 2019 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 134 ancestors have a recall of any class.
- Of its descendants, K241406 (Wontech Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K171009.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223727 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223727: Lavieen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223727
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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