510(k) · Cleared
ClearedPolris LV
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 Apr 14, 2003 as substantially equivalent to K024064 (Syneron Medical, Ltd., 2003) and 3 other predicates after an 83-day review. Its family tree reaches back 9 generations to 1995. 680 later devices descend from it.
- Decided
- Apr 14, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K943450 (1995). 61 ancestors in all, the oldest K800617 (1980). 680 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 1 generation backK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- This deviceK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · cites it directly · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005
- Descendant · 2 generations on · 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
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 1 generation backK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- This deviceK030186 Polris LVSyneron Medical, Ltd. · 2003
Showing 5 of 680 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 680 · See all- K031671Polaris WRSyneron Medical, Ltd. · 2003 · cites it directly678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 2 generations on476descendants
- K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · cites it directly456descendants
- K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · 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 |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −1 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| 0 (this device) | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +1 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +1 | K052324 | Polaris LV, Lva Applicator | Syneron Medical, Ltd. | 2005 | — |
| +2 | 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 | — |
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 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 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? (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 DS Cleared while this submission was under review Summary page 1…y equivalent to a combination of the following devices: the Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064; the PhotoDerm Nd:YAG Accessory, manufactured by ESC Medical Ltd., and subject of K… | 2003 |
| * | K980537 | ND: Yag Accessory for Photoderm SystemSummary page 1…neron Medical Ltd. and subject of K024064; the PhotoDerm Nd:YAG Accessory, manufactured by ESC Medical Ltd., and subject of K980537; the SLP 1000, manufactured by Palomar Medical Technologies Inc., and subject of KO 13028; the… | 1998 |
| * | K013028 | Palomar SLP 1000 | 2001 |
| * | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Summary page 1…logies Inc., and subject of KO 13028; the Dornier Medilas D SkinPulse Laser, manufactured by DornierMedTech, and subject of K020339. Device Description: The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris… | 2002 |
What descends from it? (680)
See all 6804 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 8 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 2 of the 61 ancestors have a recall of any class.
- Of its descendants, K031671 (Syneron Medical, Ltd., 2003) has gone furthest, with 678 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 LV is indicated for treatment of vascular lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030186: Polris LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030186
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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