510(k) · Cleared
ClearedCheveux Diode Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Medical Technologies, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jun 16, 2010 as substantially equivalent to K003614 (Coherent Star, 2001) after a 77-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- Jun 16, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003614 (2001). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003614 Lightsheer Pulsed Diode Array Laser SystemCoherent Star · 2001 · Recalled
- This deviceK100893 Cheveux Diode Laser SystemSandstone Medical Technologies, LLC · 2010
- Descendant · cites it directly · 4 of its ownK120622 Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK193426 Elite iQCynosure, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK162765 Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK123777 Multilaser SystemUltralight Laser Technologies, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK240396 Elite iQ PRO (M122K1)Cynosure, LLC · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K120622Palomar Vectus LaserPalomar Medical Technologies, Inc. · 2012 · cites it directly4descendants
- K193426Elite iQCynosure, LLC · 2020 · 2 generations on1descendant
- K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd. · 2017 · 2 generations on1descendant
- K123777Multilaser SystemUltralight Laser Technologies, LLC · 2013 · cites it directly1descendant
- K240396Elite iQ PRO (M122K1)Cynosure, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003614 | Lightsheer Pulsed Diode Array Laser System | Coherent Star | 2001 | 2 |
| 0 (this device) | K100893 | Cheveux Diode Laser System | Sandstone Medical Technologies, LLC | 2010 | — |
| +1 | K120622 | Palomar Vectus Laser | Palomar Medical Technologies, Inc. | 2012 | — |
| +2 | K193426 | Elite iQ | Cynosure, LLC | 2020 | — |
| +2 | K162765 | Venus Velocity Diode Laser System | Venus Concept, Ltd. | 2017 | — |
| +1 | K123777 | Multilaser System | Ultralight Laser Technologies, LLC | 2013 | — |
| +3 | K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…nstrument, Surgical, Powered, laser 79-GEX, 21 OFR 878-48 Legally Marketed Predicate Device(s): LightSheer Diode Laser System K003614 Description of the Cheveux Diode The Cheveux Diode Laser System delivers laser light with an Laser System… | 2001 |
What descends from it? (8)
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Cheveux Diode Laser System is indicated for:
Hair Removal
Permanent hair reduction
Treatment of vascular lesions
Treatment of benign pigmented lesions
Treatment of Leg Veins
Treatment for pseudofolliculitis barbae
The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100893: Cheveux Diode 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/K100893
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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