510(k) · Cleared
ClearedModification to Aurora 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 Dec 10, 2003 as substantially equivalent to K031988 (Syneron Medical, Ltd., 2003) after a 27-day review. Its family tree reaches back 9 generations to 1995. 303 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K943450 (1995). 39 ancestors in all, the oldest K800617 (1980). 303 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK021149 Aurora DSSyneron Medical, Ltd. · 2002
- 1 generation backK031988 Aurora DSSyneron Medical, Ltd. · 2003
- This deviceK033586 Modification to Aurora DSSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
- Descendant · 2 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 3 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 3 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 4 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK021149 Aurora DSSyneron Medical, Ltd. · 2002
- 1 generation backK031988 Aurora DSSyneron Medical, Ltd. · 2003
- This deviceK033586 Modification to Aurora DSSyneron Medical, Ltd. · 2003
Showing 5 of 303 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 303 · See all- K041969Aurora DSSyneron Medical, Ltd. · 2004 · cites it directly302descendants
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 2 generations on301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 3 generations on263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 3 generations on230descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −4 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −2 | K021149 | Aurora DS | Syneron Medical, Ltd. | 2002 | — |
| −1 | K031988 | Aurora DS | Syneron Medical, Ltd. | 2003 | — |
| 0 (this device) | K033586 | Modification to Aurora DS | Syneron Medical, Ltd. | 2003 | — |
| +1 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
| +2 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +3 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 25 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | K031988 | Aurora DSSummary page 1…7424, Fax +972.4. 909-7417 Name of the Device: Aurora DS Predicate Devices: This is a Special 5 10(k) for the Aurora DS that was cleared under K03 1988. Device Description: The Aurora DS is a device that is used for non-invasive hair removal. The… | 2003 |
What descends from it? (303)
See all 3031 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041969 | Aurora DS | 2004 | 302 |
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 9 months on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K041969 (Syneron Medical, Ltd., 2004) has gone furthest, with 302 descendants of its own.
- 1 other device also cites its predicate K031988.
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/K033586 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033586: Modification to Aurora DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033586
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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