510(k) · Cleared
ClearedCooltouch, Model Ctev
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Star Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 25, 2006 after a 108-day review. The FDA summary names its predicate without a number. 234 later devices descend from it.
- Decided
- Sep 25, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
234 later devices descend from it, 4 citing it directly.
- This deviceK061618 Cooltouch, Model CtevNew Star Lasers, Inc. · 2006
- 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 · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · cites it directly · 128 of its ownK082225 15W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008
Showing 5 of 234 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 234 · 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
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K08222515W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008 · cites it directly128descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061618 | Cooltouch, Model Ctev | New Star Lasers, Inc. | 2006 | — |
| +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 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +1 | K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470 | Biolitec, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 11 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 14 | 0 |
| 2021 | 11 | 0 |
| 2022 | 23 | 0 |
| 2023 | 14 | 0 |
| 2024 | 25 | 0 |
| 2025 | 30 | 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? (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 |
|---|---|---|---|
| * | — | CoolTouch Inc. Model CTEV (NS-160) Nd:YAG Laser Systems Named without a submission number |
What descends from it? (234)
See all 2344 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?
- Of its descendants, K073063 (Biolitec, Inc., 2008) has gone furthest, with 202 descendants of its own.
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 CTEV Nd:YAG Laser System is indicated for the treatment of
superficial incompetent tributary veins associated with varicose veins and varicosities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061618: Cooltouch, Model Ctev.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061618
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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