510(k) · Cleared
ClearedCooltouch Varizoom
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 Oct 2, 2001 as substantially equivalent to K983984 (Laser Aesthetics, Inc., 1999) after a 27-day review. Its family tree reaches back 1 generation to 1999. 519 later devices descend from it.
- Decided
- Oct 2, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983984 (1999). 519 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK983984 Cooltouch V ND:YagLaser Aesthetics, Inc. · 1999
- This deviceK012982 Cooltouch VarizoomNew Star Lasers, Inc. · 2001
- 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 · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 519 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 519 · 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
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983984 | Cooltouch V ND:Yag | Laser Aesthetics, Inc. | 1999 | — |
| 0 (this device) | K012982 | Cooltouch Varizoom | New Star Lasers, Inc. | 2001 | — |
| +1 | K032459 | Profile 1320 Laser System | Sciton, Inc | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 20 | 0 |
| 2015 | 20 | 0 |
| 2016 | 32 | 0 |
| 2017 | 24 | 0 |
| 2018 | 25 | 0 |
| 2019 | 14 | 0 |
| 2020 | 33 | 0 |
| 2021 | 27 | 0 |
| 2022 | 42 | 0 |
| 2023 | 32 | 0 |
| 2024 | 63 | 0 |
| 2025 | 61 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | K983984 | Cooltouch V ND:YagSummary page 1…System Handpiece Accessory to Laser Surgical Instruments 79-GEX The predicate device is the CoolTouch Corporation Model CoolTouch “Varia” Nd:YAG Laser System, 510(k) # K983984, July 7, 1999. The beam delivery system was described in the 510(k); the cooling handpiece was also described in detail as an acc… | 1999 |
What descends from it? (519)
See all 5191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032459 | Profile 1320 Laser System | 2004 | 518 |
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?
- Its one ancestor has no recall.
- Of its descendants, K032459 (Sciton, Inc, 2004) has gone furthest, with 518 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 VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch “Varia” Nd:YAG Laser System, which has been cleared for the following indications:
Hair removal (destruction of hair follicles) in all skin types and for soft tissue applications. For coagulation and hemostasis of vascular lesions. For pigmented lesions to reduce lesion size, for patients that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
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/K012982 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012982: Cooltouch Varizoom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012982
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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