510(k) · Cleared
ClearedDepilase Twin Lase Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depilase Group, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Feb 22, 2002 as substantially equivalent to K990718 (Laserscope, 2000) and 4 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1996. 106 later devices descend from it.
- Decided
- Feb 22, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K963094 (1996). 19 ancestors in all, the oldest K950019 (1995). 106 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 4 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 3 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 2 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 1 generation backK984601 Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
- This deviceK020412 Depilase Twin Lase Laser SystemDepilase Group, Ltd. · 2002
- Descendant · cites it directly · 104 of its ownK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- Descendant · 2 generations on · 96 of its ownK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 3 generations on · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
- Descendant · 3 generations on · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K032218Adept 1064/532/755 LaserAdept Medical Concepts · 2003 · cites it directly104descendants
- K083207Ultrawave Iii EX 1320Quanta System Spa · 2008 · 2 generations on96descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 3 generations on57descendants
- K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · 3 generations on40descendants
- K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −4 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −3 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −2 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −1 | K984601 | Candela Gentlelase II Dermatological Laser | Candela Corp. | 1999 | — |
| 0 (this device) | K020412 | Depilase Twin Lase Laser System | Depilase Group, Ltd. | 2002 | — |
| +1 | K032218 | Adept 1064/532/755 Laser | Adept Medical Concepts | 2003 | — |
| +2 | K083207 | Ultrawave Iii EX 1320 | Quanta System Spa | 2008 | 1 |
| +3 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +3 | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | 1 |
| +3 | K130256 | MDK Multi-Applications Platform | Quanta System Spa | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 16 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 12 | 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? (5)
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 |
|---|---|---|---|
| * | K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration)Summary page 2…Equivalence Depilase believes that its DEPILASE TWIN LASE Laser System system is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of va… | 2000 |
| * | K991798 | Acme Medical Aesthetic ND:Yag LaserSummary page 2…TWIN LASE Laser System system is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of vascular lesions and the removal and permanent redu… | 2000 |
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary page 2…t reduction of unwanted hair in Fitzpatrick skin types I — VI, including suntanned skin types, and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwa… | 2000 |
| * | K984601 | Candela Gentlelase II Dermatological LaserSummary page 2…hair in Fitzpatrick skin types I — VI, including suntanned skin types, and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick… | 1999 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary page 2…including suntanned skin types, and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick skin types I — IV They therefore hav… | 2000 |
What descends from it? (106)
See all 1062 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 6 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K032218 (Adept Medical Concepts, 2003) has gone furthest, with 104 descendants of its own.
- 5 other devices also cite its predicate K990718.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The DEPILASE TWIN LASE Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I VI, including suntanned skin types.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020412: Depilase Twin Lase Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020412
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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