510(k) · Cleared
ClearedCooltouch and Cooltouch-II ND:Yag Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cooltouch Corp. · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 2002 as substantially equivalent to K962791 (New Star Lasers, Inc., 1997) after a 90-day review. Its family tree reaches back 2 generations to 1982. 668 later devices descend from it.
- Decided
- Mar 7, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820106 (1982). 6 ancestors in all. 668 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK820106 X-Ray Guaze SpongesStan-Pak Ent. · 1982
- 1 generation backK962791 New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997
- This deviceK014035 Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002
- Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 520 of its ownK022466 Profile 1320 Laser SystemSciton, Inc · 2002
- Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
- Descendant · cites it directly · 518 of its ownK032459 Profile 1320 Laser SystemSciton, Inc · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Showing 5 of 668 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 668 · See all- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
- K022466Profile 1320 Laser SystemSciton, Inc · 2002 · cites it directly520descendants
- K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 2 generations on519descendants
- K032459Profile 1320 Laser SystemSciton, Inc · 2004 · cites it directly518descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820106 | X-Ray Guaze Sponges | Stan-Pak Ent. | 1982 | — |
| −1 | K962791 | New Star Model 130 6-Watt ND: Yag Laser System | New Star Lasers, Inc. | 1997 | — |
| 0 (this device) | K014035 | Cooltouch and Cooltouch-II ND:Yag Laser Systems | Cooltouch Corp. | 2002 | — |
| +1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +1 | K022466 | Profile 1320 Laser System | Sciton, Inc | 2002 | — |
| +2 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
| +1 | K032459 | Profile 1320 Laser System | Sciton, Inc | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 0 |
| 2009 | 10 | 0 |
| 2010 | 18 | 0 |
| 2011 | 21 | 0 |
| 2012 | 19 | 0 |
| 2013 | 22 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 36 | 0 |
| 2017 | 31 | 0 |
| 2018 | 29 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 31 | 0 |
| 2022 | 51 | 0 |
| 2023 | 40 | 0 |
| 2024 | 69 | 0 |
| 2025 | 81 | 0 |
| 2026 | 46 | 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 |
|---|---|---|---|
| * | K962791 | New Star Model 130 6-Watt ND: Yag Laser SystemSummary page 1…uch-II Nd:YAG Laser System Nd: YAG Pulsed Surgical Laser Laser Surgical Instrument. 21 C.F.R. § 878.4810 New Star Lasers, Inc. Model 130 Nd:YAG Surgical Laser System (K962791). The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three intercon… | 1997 |
What descends from it? (668)
See all 6684 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 20 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
- 2 other devices also cite its predicate K962791.
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 Nd:YAG Laser Systems are indicated fer the treatment of periorbital and perioral wrinkles.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014035
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026