510(k) · Cleared
ClearedCoolSculpting Elite 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 Nov 5, 2021 as substantially equivalent to K193566 (Zeltiq Aesthetics, Inc., 2020) after a 71-day review. Its family tree reaches back 2 generations to 2019. 1 later device descends from it.
- Decided
- Nov 5, 2021
- Review
- 71 days
- Class
- Class II
- Product code
- OOK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183514 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK183514 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2019
- 1 generation backK193566 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2020 · Recalled
- This deviceK212707 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233732 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · 2024
Most influential descendants
Showing 1 of 1 · See all- K233732CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019 | — |
| −1 | K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020 | 1 |
| 0 (this device) | K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | 2021 | — |
| +1 | K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K193566 | ZELTIQ CoolSculpting SystemSummary page 4…Aesthetic Use DEVICE CLASSIFICATION: Class II, 21 CFR §878.4340 PRODUCT CODE: OOK III. PREDICATE DEVICE: ZELTIQ CoolSculpting System (K193566) IV. DEVICE DESCRIPTION: The CoolSculpting Elite System is a portable thermoelectric cooling and heating device that applies con… | 2020 |
| † | K171069 | ZELTIQ CoolSculpting System | 2017 |
| † | K162050 | ZELTIQ CoolSculpting System | 2016 |
| † | K151179 | ZELTIQ CoolSculpting System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233732 | CoolSculpting Elite System | 2024 | 0 |
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 2 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K233732 (Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics, 2024) has gone furthest, with 0 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. 2021, 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 | — |
What is it indicated for?
The CoolSculpting Elite System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back fat, banana roll, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended…
Read the full statement (250 words)
The CoolSculpting Elite System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back fat, banana roll, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submental and submandibular areas, thigh, abdomen and flank. When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatment and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting Elite System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The Zeltiq Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212707: CoolSculpting Elite System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212707
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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