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. (Acquired by Allergan Aesthetics · OOK Dermal Cooling Pack/Vacuum/Massager
Cleared on Sep 12, 2024 as substantially equivalent to K212707 (Zeltiq Aesthetics, Inc., 2021) after a 296-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Sep 12, 2024
- Review
- 296 days
- Class
- Class II
- Product code
- OOK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183514 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK183514 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2019
- 2 generations backK193566 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2020 · Recalled
- 1 generation backK212707 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. · 2021
- This deviceK233732 CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019 | — |
| −2 | K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020 | 1 |
| −1 | K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | 2021 | — |
| 0 (this device) | K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024 | — |
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 K212707 CoolSculpting Elite Systemscore 5.6 · 2 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 |
|---|---|---|---|
| * | K212707 | CoolSculpting Elite SystemSummary page 5…OOK Dermal Cooling Pack/Vacuum/Massager III. PREDICATE DEVICE Predicate Device CoolSculpting Elite System K212707 (cleared on November 5, 2021) IV. DEVICE DESCRIPTION The CoolSculpting Elite System is a portable thermoelectric cooling d… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2024, 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. It can be used in cooling or heating mode. Cooling Mode * 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. * Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. *…
Read the full statement (214 words)
The CoolSculpting Elite System is a skin cooling or heating device. It can be used in cooling or heating mode.
Cooling Mode
* 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.
* Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2.
* 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.
* Can be used to minimize pain and thermal injury during laser and dermatological treatments.
* Can be used as a local anesthetic for procedures that induce minor local discomfort.
Heating or Cooling Mode
* Can be used to minimize pain post-trauma and post-surgery.
* Can be used to provide temporary relief of minor aches, pains, and muscle spasms.
* The ZELTIQ Pretreatment Skin Wipe and gel pad 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/K233732 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233732: CoolSculpting Elite System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233732
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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