510(k) · Cleared
ClearedPolaris DS/Comet
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 Nov 8, 2004 as substantially equivalent to K024064 (Syneron Medical, Ltd., 2003) and 3 other predicates after a 110-day review. Its family tree reaches back 12 generations to 1995. 301 later devices descend from it.
- Decided
- Nov 8, 2004
- Review
- 110 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K943450 (1995). 85 ancestors in all, the oldest K800617 (1980). 301 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 deviceK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- Descendant · cites it directly · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 2 generations on · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 2 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
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 deviceK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
Showing 5 of 301 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 301 · See all- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · cites it directly299descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on230descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on229descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
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) | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| +1 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +2 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 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 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K024064 | Polaris DSSummary page 1…owered surgical instruments (21 CFR 878.4810, procode GEX): Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064. Polaris WR, manufactured by Syneron Medical Ltd. and subject of K031671. LightShee… | 2003 |
| * | K031671 | Polaris WRSummary page 1…Syneron Medical Ltd. and subject of K024064. Polaris WR, manufactured by Syneron Medical Ltd. and subject of K031671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd.… | 2003 |
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…manufactured by Syneron Medical Ltd. and subject of K031671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd. and subject of K030805 Device Description: The Polaris DS / Comet… | 2001 |
| * | K030805 | Mythos 500Summary page 1…31671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd. and subject of K030805 Device Description: The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction… | 2003 |
What descends from it? (301)
See all 3012 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 9 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 85 ancestors have a recall of any class.
- Of its descendants, K053540 (Intermedic Arfran, SA, 2006) has gone furthest, with 299 descendants of its own.
- 1 other device also cites its predicate K024064.
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 DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041959: Polaris DS/Comet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041959
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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