510(k) · Cleared
ClearedDepilase Yag Lase Plus 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 27, 2002 as substantially equivalent to K990718 (Laserscope, 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Feb 27, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963094 (1996). 12 ancestors in all, the oldest K950019 (1995). 1 later device descends from it, 1 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 backK991798 Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000
- This deviceK020463 Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK021650 Athoscan for the Athos Laser Constans Cooling Hand Piece for the…Quantel Medical · 2002
Most influential descendants
Showing 1 of 1 · See all- K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical · 2002 · cites it directly0descendants
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 | K991798 | Acme Medical Aesthetic ND:Yag Laser | Altus Medical | 2000 | — |
| 0 (this device) | K020463 | Depilase Yag Lase Plus Laser System | Depilase Group, Ltd. | 2002 | — |
| +1 | K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | Quantel Medical | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration)Summary page 2…d skin types. H1. Summary of Substantial Equivalence Depilase believes that its DEPILASE YAG LASE PLUS Laser System is substantially equivalent to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG lasers, previously cleared for both the coagulation and haemostasis of… | 2000 |
| * | K991798 | Acme Medical Aesthetic ND:Yag LaserSummary page 2…ence Depilase believes that its DEPILASE YAG LASE PLUS Laser System is substantially equivalent to the Laserscope Lyra (K990718), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG lasers, previously cleared for both the coagulation and haemostasis of vascular lesions and the removal and permanent re… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | 2002 | 0 |
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 4 companies; a new generation was cleared every 12 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K021650 (Quantel Medical, 2002) has gone furthest, with 0 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 YAG LASE PLUS 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/K020463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020463: Depilase Yag Lase Plus 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/K020463
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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