510(k) · Cleared
ClearedCooltouch, Model NS 160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cooltouch, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2004 as substantially equivalent to K023543 (Diomed, Inc., 2002) and 3 other predicates after a 173-day review. Its family tree reaches back 8 generations to 1995. 204 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 173 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 204 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- This deviceK040921 Cooltouch, Model NS 160Cooltouch, Inc. · 2004
- Descendant · cites it directly · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · 2 generations on · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 204 · See all- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · cites it directly202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
- K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · 2 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| 0 (this device) | K040921 | Cooltouch, Model NS 160 | Cooltouch, Inc. | 2004 | — |
| +1 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +2 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +2 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 23 | 0 |
| 2025 | 28 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K023543 | Evlt Kit and D15PLUS and D30PLUS DiodeSummary page 1…: Laser Surgical Instrument. 21 C.F.R. § 878.4810 Legally Marketed Predicate Device: Diomed 8IOnm Surgical Laser, K023543, K012398 Biolitec Ceralas D10-60 810nm Diode Laser, K030700… | 2002 |
| * | K012398 | Diomed 15 Diode LaserSummary page 1…Laser Surgical Instrument. 21 C.F.R. § 878.4810 Legally Marketed Predicate Device: Diomed 8IOnm Surgical Laser, K023543, K012398 Biolitec Ceralas D10-60 810nm Diode Laser, K030700 Biol… | 2002 |
| * | K030700 | Ceralas D 10-60 810NM Laser System with Endo Laser Vein System KitSummary page 1….4810 Legally Marketed Predicate Device: Diomed 8IOnm Surgical Laser, K023543, K012398 Biolitec Ceralas D10-60 810nm Diode Laser, K030700 Biolitec Ceralas D 980nm Diode Laser, K024088 Description of the CoolTouch The Cool… | 2003 |
| * | K024088 | Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25Summary page 1…012398 Biolitec Ceralas D10-60 810nm Diode Laser, K030700 Biolitec Ceralas D 980nm Diode Laser, K024088 Description of the CoolTouch The CoolTouch NS-160 Nd:YAG Laser System is an Nd:YAG Laser Systems: ND:YAG… | 2003 |
What descends from it? (204)
See all 2042 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 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K073063 (Biolitec, Inc., 2008) has gone furthest, with 202 descendants of its own.
- 7 other devices also cite its predicate K023543.
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 CoolTouch NS-160 Nd:YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040921: Cooltouch, Model NS 160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040921
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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