510(k) · Cleared
ClearedZELTIQ CoolSculpting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeltiq Aesthetics, Inc. · OOK Dermal Cooling Pack/Vacuum/Massager
Cleared on Jan 14, 2019 after a 27-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jan 14, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- OOK
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK183514 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK193566 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK212707 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK233732 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · 2024
Most influential descendants
Showing 3 of 3 · See all- K193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2020 · cites it directly2descendants
- K212707CoolSculpting Elite SystemZeltiq Aesthetics, Inc. · 2021 · 2 generations on1descendant
- K233732CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019 | — |
| +1 | K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020 | 1 |
| +2 | K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | 2021 | — |
| +3 | K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193566 | ZELTIQ CoolSculpting System | 2020 | 2 |
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, K193566 (Zeltiq Aesthetics, Inc., 2020) has gone furthest, with 2 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. 2019, 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/K183514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183514: ZELTIQ CoolSculpting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183514
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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