510(k) · Cleared
ClearedPolaris WR
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 1, 2003 as substantially equivalent to K030186 (Syneron Medical, Ltd., 2003) and 2 other predicates after a 186-day review. Its family tree reaches back 11 generations to 1995. 678 later devices descend from it.
- Decided
- Dec 1, 2003
- Review
- 186 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K943450 (1995). 81 ancestors in all, the oldest K800617 (1980). 678 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · cites it directly · 301 of its ownK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 2 generations on · 297 of its ownK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 6 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 5 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 4 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK031671 Polaris WRSyneron Medical, Ltd. · 2003
Showing 5 of 678 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 678 · See all- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · cites it directly476descendants
- K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · cites it directly301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
- K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006 · 2 generations on297descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −6 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −5 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −4 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −3 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −1 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| 0 (this device) | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +1 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +1 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 16 | 0 |
| 2009 | 16 | 0 |
| 2010 | 19 | 0 |
| 2011 | 14 | 0 |
| 2012 | 15 | 0 |
| 2013 | 21 | 0 |
| 2014 | 28 | 0 |
| 2015 | 24 | 0 |
| 2016 | 38 | 0 |
| 2017 | 35 | 0 |
| 2018 | 34 | 0 |
| 2019 | 24 | 0 |
| 2020 | 40 | 0 |
| 2021 | 32 | 0 |
| 2022 | 50 | 0 |
| 2023 | 45 | 0 |
| 2024 | 76 | 0 |
| 2025 | 88 | 0 |
| 2026 | 51 | 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 |
|---|---|---|---|
| * | K030186 | Polris LVSummary page 1…powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris LV, manufactured by Syneron Medical Ltd. and subject of K030 186; Coolglide, manufactured by Altus Medical Inc. and subject of K023954; ThermaCool TC,… | 2003 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…V, manufactured by Syneron Medical Ltd. and subject of K030 186; Coolglide, manufactured by Altus Medical Inc. and subject of K023954; ThermaCool TC, Manufactured by Thermage Inc. and subject of K030 142. Device Description: The Polaris WR… | 2003 |
| * | K030142 | Thermacool TC SystemSummary page 1…glide, manufactured by Altus Medical Inc. and subject of K023954; ThermaCool TC, Manufactured by Thermage Inc. and subject of K030 142. Device Description: The Polaris WR is a device that is used for non invasive wrinkles treatment. The Polar… | 2003 |
What descends from it? (678)
See all 6788 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051214 | Aluma Skin Renewal System | 2005 | 476 |
| K041959 | Polaris DS/Comet | 2004 | 301 |
| K070004 | Accent | 2007 | 181 |
| K053616 | Polaris WR, ST Applicator | 2006 | 133 |
| K070388 | Profile Multi-Platform System | 2007 | 129 |
| K083461 | Imagine TC Skin Therapy System | 2009 | 101 |
| K100586 | Venus Freeze System | 2010 | 31 |
| K113868 | Eplus Skin Treatment System | 2012 | 0 |
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.
- 3 of the 81 ancestors have a recall of any class.
- Of its descendants, K051214 (Lumenis, Inc., 2005) has gone furthest, with 476 descendants of its own.
- 3 other devices also cite its predicate K030186.
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 Polaris WR is indicated for non invasive wrinkles treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031671: Polaris WR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031671
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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