De Novo · Granted
GrantedZeltiq Aesthetics Dermal Cooling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeltiq Aesthetics · OOK Dermal Cooling Pack/Vacuum/Massager
Granted on Aug 24, 2010 as a new device type through De Novo after a 315-day review. 32 later devices descend from it.
- Decided
- Aug 24, 2010
- Review
- 315 days
- Class
- Class II
- Product code
- OOK
- Recalls
- None
32 later devices descend from it, 4 citing it directly.
- This deviceDEN090002 Zeltiq Aesthetics Dermal Cooling DeviceZeltiq Aesthetics · 2010
- Descendant · cites it directly · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- Descendant · cites it directly · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- Descendant · cites it directly · 27 of its ownK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- Descendant · cites it directly · 26 of its ownK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · cites it directly31descendants
- K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014 · cites it directly30descendants
- K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015 · cites it directly27descendants
- K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015 · cites it directly26descendants
- K150724SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN090002 | Zeltiq Aesthetics Dermal Cooling Device | Zeltiq Aesthetics | 2010 | — |
| +1 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| +1 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| +1 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| +1 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| +2 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OOK? 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 OOK device
- #1 K233732 CoolSculpting Elite Systemscore 8.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (32)
See all 324 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, K120023 (Zeltiq Aesthetics, Inc., 2012) has gone furthest, with 31 descendants of its own.
How does its category compare?
All OOK devicesOOK Dermal Cooling Pack/Vacuum/Massager: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OOK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OOK
Too few OOK 510(k)s in any year since 2007 to give a median.
Recalls per year · OOK
No recall names OOK since 2007.
Adverse event reports per year · OOK
901in 2025
MAUDE reports naming product code OOK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 21 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 49 |
| 2020 | 1 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 1,161 |
| 2022 | 0 | — | 0 | 1,978 |
| 2023 | 0 | — | 0 | 5,499 |
| 2024 | 1 | — | 0 | 1,277 |
| 2025 | 0 | — | 0 | 901 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN090002 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN090002: Zeltiq Aesthetics Dermal Cooling Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN090002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026