510(k) · Cleared
ClearedCooltouch ND:Yag Laser Systems, Models CT3S and 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 Aug 9, 2005 after a 69-day review. The FDA summary names its predicate without a number. 230 later devices descend from it.
- Decided
- Aug 9, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
230 later devices descend from it, 3 citing it directly.
- This deviceK051434 Cooltouch ND:Yag Laser Systems, Models CT3S and CtevNew Star Lasers, Inc. · 2005
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, 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 · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- 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 · 2 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051434 | Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev | New Star Lasers, Inc. | 2005 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, 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 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 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 NS-160 (CTEV) and CT3S Nd:YAG Laser Systems Named without a submission number |
What descends from it? (230)
See all 2303 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, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 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?
In addition to previously cleared indications for use, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are indicated for the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051434: Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051434
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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