510(k) · Cleared
ClearedCooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icn Pharmaceuticals, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 22, 2002 as substantially equivalent to K962791 (New Star Lasers, Inc., 1997) after an 88-day review. Its family tree reaches back 2 generations to 1982. 575 later devices descend from it.
- Decided
- Nov 22, 2002
- Review
- 88 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. 575 later devices descend from it, 2 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 deviceK022817 Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag…Icn Pharmaceuticals, Inc. · 2002
- 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
- Descendant · cites it directly · 317 of its ownK030846 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · 3 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
Showing 5 of 575 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 575 · See all- K032459Profile 1320 Laser SystemSciton, Inc · 2004 · cites it directly518descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K030846Candela Smoothbeam Laser SystemCandela Corp. · 2003 · cites it directly317descendants
- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 3 generations on284descendants
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) | K022817 | Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser… | Icn Pharmaceuticals, Inc. | 2002 | — |
| +1 | K032459 | Profile 1320 Laser System | Sciton, Inc | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K030846 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| +2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +3 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 15 | 0 |
| 2008 | 20 | 0 |
| 2009 | 11 | 0 |
| 2010 | 15 | 0 |
| 2011 | 17 | 0 |
| 2012 | 13 | 0 |
| 2013 | 18 | 0 |
| 2014 | 23 | 0 |
| 2015 | 21 | 0 |
| 2016 | 33 | 0 |
| 2017 | 26 | 0 |
| 2018 | 27 | 0 |
| 2019 | 16 | 0 |
| 2020 | 34 | 0 |
| 2021 | 28 | 0 |
| 2022 | 45 | 0 |
| 2023 | 35 | 0 |
| 2024 | 65 | 0 |
| 2025 | 64 | 0 |
| 2026 | 39 | 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…21 C.F.R. Legally Marketed Predicate Device: New Star Lasers, Inc. Model 130 NdiYAG Surgical Laser System (K962791). Description of the CoolTouch The CooITouch Nd:YAG Laser Systems are ND;YAG Nd:YAG Laser Systems: lasers… | 1997 |
What descends from it? (575)
See all 5752 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, K032459 (Sciton, Inc, 2004) has gone furthest, with 518 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 for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022817: Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022817
Report an extraction error
Are you the manufacturer?
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