510(k) · Cleared
ClearedPolaris WR, ST Applicator
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 Mar 14, 2006 as substantially equivalent to K031671 (Syneron Medical, Ltd., 2003) after a 76-day review. Its family tree reaches back 12 generations to 1995. 133 later devices descend from it.
- Decided
- Mar 14, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K943450 (1995). 82 ancestors in all, the oldest K800617 (1980). 133 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- This deviceK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- This deviceK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −1 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| 0 (this device) | K053616 | Polaris WR, ST Applicator | Syneron Medical, Ltd. | 2006 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 18 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K031671 | Polaris WRSummary page 1….909-6200, Fax +972.4. 909-6202 Name of the Device: Polaris WR, ST Applicator Predicate Devices: This is a Special 510(k) for the Polaris WR that was cleared under K03 1671. Device Description: The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is bas… | 2003 |
What descends from it? (133)
See all 1332 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 11 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 3 of the 82 ancestors have a recall of any class.
- Of its descendants, K070388 (Sciton, Inc, 2007) has gone furthest, with 129 descendants of its own.
- 7 other devices also cite its predicate K031671.
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, ST applicator is indicated for non invasive wrinkles treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053616: Polaris WR, ST Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053616
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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