510(k) · Cleared
ClearedAura Isurgical Laser System & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Nov 17, 2003 after a 332-day review. The FDA summary names its predicate without a number. 198 later devices descend from it.
- Decided
- Nov 17, 2003
- Review
- 332 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
198 later devices descend from it, 3 citing it directly.
- This deviceK024206 Aura Isurgical Laser System & AccessoriesLaserscope · 2003
- Descendant · cites it directly · 136 of its ownK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
- Descendant · 2 generations on · 133 of its ownK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 3 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 198 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 198 · See all- K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp. · 2005 · cites it directly136descendants
- K050673Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · 2 generations on133descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 3 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024206 | Aura Isurgical Laser System & Accessories | Laserscope | 2003 | — |
| +1 | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | Candela Corp. | 2005 | — |
| +2 | K050673 | Candela Family of Pulse Dye Laser Systems | Candela Corp. | 2005 | 2 |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +3 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 0 |
| 2022 | 22 | 0 |
| 2023 | 12 | 0 |
| 2024 | 21 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 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? (3)
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 |
|---|---|---|---|
| * | — | ClearLight Phototherapy System Model C420 Named without a submission number | |
| * | — | Laserscope Lyra Laser System and Accessories Named without a submission number | |
| * | — | Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength… Named without a submission number |
What descends from it? (198)
See all 1983 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?
- Of its descendants, K043251 (Candela Corp., 2005) has gone furthest, with 136 descendants of its own.
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 Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024206: Aura Isurgical Laser System & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024206
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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