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 Jul 9, 2002 as substantially equivalent to K991935 (Esc Medical Systems, Ltd., 2000) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1995. 750 later devices descend from it.
- Decided
- Jul 9, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K943450 (1995). 37 ancestors in all, the oldest K800617 (1980). 750 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 2 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 1 generation backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- This deviceK021149 Aurora DSSyneron Medical, Ltd. · 2002
- Descendant · cites it directly · 681 of its ownK024064 Polaris DSSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 4 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 3 generations on · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 750 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 750 · See all- K024064Polaris DSSyneron Medical, Ltd. · 2003 · cites it directly681descendants
- K030186Polris LVSyneron Medical, Ltd. · 2003 · 2 generations on680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 4 generations on476descendants
- K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on456descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −6 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −2 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −1 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| 0 (this device) | K021149 | Aurora DS | Syneron Medical, Ltd. | 2002 | — |
| +1 | K024064 | Polaris DS | Syneron Medical, Ltd. | 2003 | — |
| +2 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +3 | K052324 | Polaris LV, Lva Applicator | Syneron Medical, Ltd. | 2005 | — |
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 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 17 | 0 |
| 2009 | 18 | 0 |
| 2010 | 21 | 0 |
| 2011 | 14 | 0 |
| 2012 | 17 | 0 |
| 2013 | 24 | 0 |
| 2014 | 30 | 0 |
| 2015 | 28 | 0 |
| 2016 | 43 | 0 |
| 2017 | 40 | 0 |
| 2018 | 34 | 0 |
| 2019 | 29 | 0 |
| 2020 | 44 | 0 |
| 2021 | 38 | 0 |
| 2022 | 55 | 0 |
| 2023 | 49 | 0 |
| 2024 | 78 | 0 |
| 2025 | 90 | 0 |
| 2026 | 55 | 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 |
|---|---|---|---|
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…ora DS is substantially equivalent to a combination of the. EpiLight, manufactured by ESC Medical Systems Ltd. and subject of K991935, the Compu-Blend, manufactured by R.A. Fischer Co. Inc. and subject of K95403 1, and the ThermaCool,… | 2000 |
| * | K954031 | Compu-Blend EpilatorSummary page 1…red by ESC Medical Systems Ltd. and subject of K991935, the Compu-Blend, manufactured by R.A. Fischer Co. Inc. and subject of K95403 1, and the ThermaCool, manufactured by Thermage Inc. and subject of K000944. Device Description: The Aurora… | 1996 |
| * | K000944 | Thermage Thermacool SystemSummary page 1…nufactured by R.A. Fischer Co. Inc. and subject of K95403 1, and the ThermaCool, manufactured by Thermage Inc. and subject of K000944. Device Description: The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS tr… | 2000 |
What descends from it? (750)
See all 7503 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 7 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K024064 (Syneron Medical, Ltd., 2003) has gone furthest, with 681 descendants of its own.
- 9 other devices also cite its predicate K991935.
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/K021149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021149: Aurora DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021149
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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