510(k) · Cleared
ClearedARION
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavelight Laser Technologie AG · GEX Powered Laser Surgical Instrument
Cleared on Sep 29, 2004 as substantially equivalent to K983977 (Light Age, Inc., 1999) and 7 other predicates after a 16-day review. Its family tree reaches back 6 generations to 1996. 114 later devices descend from it.
- Decided
- Sep 29, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K963094 (1996). 20 ancestors in all, the oldest K950019 (1995). 114 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 5 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 4 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 3 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 2 generations backK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
- 1 generation backK024335 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
- This deviceK042474 ARIONWavelight Laser Technologie AG · 2004
- Descendant · cites it directly · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 58 of its ownK090571 Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · See all- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · cites it directly112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
- K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009 · cites it directly58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −5 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −4 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −3 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −2 | K994260 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 2000 | — |
| −1 | K024335 | Candela Gentlelase Family of Laser Systems | Candela Corp. | 2003 | 1 |
| 0 (this device) | K042474 | ARION | Wavelight Laser Technologie AG | 2004 | — |
| +1 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K090571 | Alma Lasers ALEX755 Module | Alma Lasers, Ltd. | 2009 | — |
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 | 3 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 18 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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? (8)
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 |
|---|---|---|---|
| * | K983977 | Light Age Epicare Alexandrite LaserSummary page 1…: Dermatology and Plastic Surgery 3. Predicate Devices The ARION laser system is substantially equivalent to the Light Age Epicare Model LPX (K983977), the Sharplan Epiouch 5000 Alexandrite laser system (K971874), the Sharplan EpiTouch 5000 Alexandrite laser system… | 1999 |
| * | K971874 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…The ARION laser system is substantially equivalent to the Light Age Epicare Model LPX (K983977), the Sharplan Epiouch 5000 Alexandrite laser system (K971874), the Sharplan EpiTouch 5000 Alexandrite laser system (K973354), the Candela Gentlelase family of laser systems (K02426… | 1997 |
| * | K973354 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…are Model LPX (K983977), the Sharplan Epiouch 5000 Alexandrite laser system (K971874), the Sharplan EpiTouch 5000 Alexandrite laser system (K973354), the Candela Gentlelase family of laser systems (K024260), the Candela Gentielase family of laser systems (K024335), t… | 1997 |
| * | K024260 | Candela Gentlelase Family of Laser SystemsSummary page 1…00 Alexandrite laser system (K971874), the Sharplan EpiTouch 5000 Alexandrite laser system (K973354), the Candela Gentlelase family of laser systems (K024260), the Candela Gentielase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure… | 2003 |
| * | K024335 | Candela Gentlelase Family of Laser SystemsSummary page 1…ch 5000 Alexandrite laser system (K973354), the Candela Gentlelase family of laser systems (K024260), the Candela Gentielase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure Apogee-Tks II(K031488), and the Cynosure Apogee-Tks (K992… | 2003 |
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary page 1…3354), the Candela Gentlelase family of laser systems (K024260), the Candela Gentielase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure Apogee-Tks II(K031488), and the Cynosure Apogee-Tks (K992757).… | 2000 |
| * | K031488 | Cynosure Apogee-TKS II Dermatological LaserSummary page 1…of laser systems (K024260), the Candela Gentielase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure Apogee-Tks II(K031488), and the Cynosure Apogee-Tks (K992757).… | 2003 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary page 1…Gentielase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure Apogee-Tks II(K031488), and the Cynosure Apogee-Tks (K992757). 0024… | 2000 |
What descends from it? (114)
See all 1142 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 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K081352 (Sciton, Inc, 2008) has gone furthest, with 112 descendants of its own.
- 1 other device also cites its predicate K983977.
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?
1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042474: ARION.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042474
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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