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Cryolipolysis (fat freezing)

CoolSculpting Elite

ZELTIQ Aesthetics, Inc. (Allergan Aesthetics, an AbbVie company)

FDA-cleared device (510(k)) — cleared, not approvedChecked Sep 14, 2026 · Read on the pages cited

What it is

Maker
ZELTIQ Aesthetics, Inc. (Allergan Aesthetics, an AbbVie company)
Category
Cryolipolysis (fat freezing)
Also called
CoolSculpting, Cool Sculpting, CoolSculpting Elite System, cryolipolysis

FDA status

Pathway
FDA-cleared device (510(k)) — cleared, not approved
First approved or cleared
Not confirmed — see the research notes

Research notes

K233732 cleared 2024-09-12 (regulation 21 CFR 878.4340, contact cooling system for aesthetic use, product code OOK, Class II). The device type traces to De Novo DEN090002 granted to ZELTIQ Aesthetics on 2010-08-24 (regulation 878.4340); the De Novo's original indication text was not opened. openFDA also lists earlier ZELTIQ 510(k)s from 2008-2009 (not opened). Because the first fat-reduction authorization year was not confirmed, the first authorization year is not recorded here. The indications above are from the 2024 clearance only. No device labeling/manual was opened, so no warnings are recorded.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Cooling mode: cold-assisted breakdown of fat (lipolysis) of the upper arm, bra fat, back fat, banana roll, thigh, abdomen and flank in people with a BMI of 30 or less
  • Cooling mode: cold-assisted lipolysis of the area under the chin and jaw (submental and submandibular) in people with a BMI up to 46.2
  • Intended to affect the appearance of visible fat bulges in those areas; when used under the chin it can also affect the appearance of lax tissue there
  • Cooling mode: can be used to minimize pain and thermal injury during laser and dermatological treatments, and as a local anesthetic for procedures causing minor discomfort
  • Heating or cooling mode: can be used to minimize pain after injury or surgery, and for temporary relief of minor aches, pains and muscle spasms

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under K233732, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up K233732 and a number from the box

What changed at the source

Dated FDA records that concern CoolSculpting Elite, newest first. A record says what happened at the source; it is not a finding about any clinic's stock.

  1. Enforcement or recall ·

    Recall of five CoolSculpting applicator models, still open in FDA's database

    U.S. Food & Drug Administration · FDA recalls Z-1346-2022 to Z-1350-2022 (event 90331)

    On June 9, 2022 Zeltiq Aesthetics began removing its parallel plate applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax and CoolFit, cleared under K181740) because of an increased rate of complaints of paradoxical hyperplasia during 2019–2021. FDA classified it as a Class 2 device recall; its record still read "Open, Classified" when checked, meaning not all products had been corrected or removed.

    What this source establishes
    That these five applicator models were recalled for an increased complaint rate of paradoxical hyperplasia, and the recall's FDA class and status.
    What it does not establish
    Whether the applicator a clinic uses is one of these models, or anything about the CoolSculpting Elite system's own clearance. Ask which applicator will be used.

    The official record (opens in a new tab) · checked Sep 25, 2026

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA 510(k) database: K233732 (CoolSculpting Elite System) (opens in a new tab)FDA database
  2. FDA 510(k) clearance letter and Indications for Use, K233732 (opens in a new tab)FDA database
  3. FDA De Novo database: DEN090002 (ZELTIQ Aesthetics Dermal Cooling Device) (opens in a new tab)FDA database

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

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