510(k) · Cleared
ClearedAurora SR
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 Oct 3, 2002 as substantially equivalent to K950493 (Esc, Energy Systems Corp., 1995) and 3 other predicates after an 83-day review. Its family tree reaches back 7 generations to 1995. 705 later devices descend from it.
- Decided
- Oct 3, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K943450 (1995). 32 ancestors in all, the oldest K800617 (1980). 705 later devices descend from it, 5 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 backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 1 generation backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- This deviceK022266 Aurora SRSyneron Medical, Ltd. · 2002
- Descendant · cites it directly · 563 of its ownK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · cites it directly · 303 of its ownK031993 Aurora SRSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 301 of its ownK050452 Aurora SR and Sra 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
Showing 5 of 705 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 705 · See all- K030426Omnilux RedPhoto Therapeutics Limited · 2003 · cites it directly563descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
- K031993Aurora SRSyneron Medical, Ltd. · 2003 · cites it directly303descendants
- K050452Aurora SR and Sra 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
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 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −1 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| +1 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +1 | K031993 | Aurora SR | Syneron Medical, Ltd. | 2003 | — |
| +2 | K050452 | Aurora SR and Sra Applicator | Syneron Medical, Ltd. | 2005 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 20 | 0 |
| 2009 | 12 | 0 |
| 2010 | 20 | 0 |
| 2011 | 11 | 0 |
| 2012 | 13 | 0 |
| 2013 | 21 | 0 |
| 2014 | 25 | 0 |
| 2015 | 31 | 0 |
| 2016 | 33 | 0 |
| 2017 | 41 | 0 |
| 2018 | 34 | 0 |
| 2019 | 27 | 0 |
| 2020 | 37 | 0 |
| 2021 | 36 | 0 |
| 2022 | 52 | 0 |
| 2023 | 45 | 0 |
| 2024 | 65 | 0 |
| 2025 | 101 | 0 |
| 2026 | 60 | 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? (4)
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 |
|---|---|---|---|
| * | K950493 | Photoderm VL.Summary page 1…valent to a combination of the following devices: the PhotoDerm VL, manufactured by ESC Medical Systems Ltd. and subject of K950493; the PhotoDerm PL, manufactured by ESC Medical Systems Ltd. and subject of K960772;… | 1995 |
| * | K960772 | Photoderm PL.Summary page 1…ESC Medical Systems Ltd. and subject of K950493; the PhotoDerm PL, manufactured by ESC Medical Systems Ltd. and subject of K960772; the ThermaCool, manufactured by Thermage Inc. and subject of K000944; the Vnus Closure… | 1996 |
| * | K000944 | Thermage Thermacool SystemSummary page 1…nufactured by ESC Medical Systems Ltd. and subject of K960772; the ThermaCool, manufactured by Thermage Inc. and subject of K000944; the Vnus Closure System, manufactured by Vnus Medical Technologies Inc. and subjec… | 2000 |
| * | K982816 | Vnus Closure SystemSummary page 1…hermage Inc. and subject of K000944; the Vnus Closure System, manufactured by Vnus Medical Technologies Inc. and subject of K9828 16. Device Description: The Aurora SR is a device that is used for treatment of superficial, benign vascular an… | 1999 |
What descends from it? (705)
See all 7055 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 8 months on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K030426 (Photo Therapeutics Limited, 2003) has gone furthest, with 563 descendants of its own.
- 1 other device also cites its predicate K950493.
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 SR is indicated for treatment of superficial, benign
vascular, and pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022266: Aurora SR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022266
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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