510(k) · Cleared
ClearedAurora DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Medical, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 1, 2003 as substantially equivalent to K021149 (Syneron Medical, Ltd., 2002) after a 35-day review. Its family tree reaches back 8 generations to 1995. 450 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943450 (1995). 38 ancestors in all, the oldest K800617 (1980). 450 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 3 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 2 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 1 generation backK021149 Aurora DSSyneron Medical, Ltd. · 2002
- This deviceK031988 Aurora DSSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 303 of its ownK033586 Modification to Aurora DSSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
- Descendant · 3 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
- Descendant · 3 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 4 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Showing 5 of 450 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 450 · See all- K033586Modification to Aurora DSSyneron Medical, Ltd. · 2003 · cites it directly303descendants
- K041969Aurora DSSyneron Medical, Ltd. · 2004 · 2 generations on302descendants
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 3 generations on299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 4 generations on263descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −3 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −2 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −1 | K021149 | Aurora DS | Syneron Medical, Ltd. | 2002 | — |
| 0 (this device) | K031988 | Aurora DS | Syneron Medical, Ltd. | 2003 | — |
| +1 | K033586 | Modification to Aurora DS | Syneron Medical, Ltd. | 2003 | — |
| +2 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
| +3 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
| +3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +4 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 12 | 0 |
| 2010 | 12 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 19 | 0 |
| 2016 | 25 | 0 |
| 2017 | 22 | 0 |
| 2018 | 18 | 0 |
| 2019 | 22 | 0 |
| 2020 | 27 | 0 |
| 2021 | 23 | 0 |
| 2022 | 36 | 0 |
| 2023 | 28 | 0 |
| 2024 | 42 | 0 |
| 2025 | 61 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K021149 | Aurora DS | 2002 |
What descends from it? (450)
See all 4502 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 1.1 years on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K033586 (Syneron Medical, Ltd., 2003) has gone furthest, with 303 descendants of its own.
- 2 other devices also cite its predicate K021149.
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 Aurora DS is indicated for non-invasive hair removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031988: Aurora DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031988
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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