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Spa Intelligence

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Product identity

What was that, exactly?

Type the name as it was said to you or printed on the box — or a number from it: an NDC, a device identifier or full UDI, a 510(k), PMA or application number. A name is matched against this site’s registry; a number can be looked up in FDA’s own records, with any recall filed under it. A match says a record exists. It never says the vial or device in front of you is that product.

Names are matched in this browser, against a copy of the registry that loaded with the page. Only when you press a lookup button is anything sent: that one name or number, to this site, which asks FDA.

Try:

A 510(k) number. Press the lookup button to search FDA records.

Registry match

CoolSculpting Elite

ZELTIQ Aesthetics, Inc. (Allergan Aesthetics, an AbbVie company) · Cryolipolysis (fat freezing)

FDA-cleared device (510(k)) — cleared, not approvedK233732 (opens in a new tab)

What it’s authorized for

  • 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

And 1 more on the full page.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product. Ask: “What’s the brand name printed on the box, vial or device panel — and may I see it?”

Official records

This looks like a 510(k) number.

Look it up in FDA and National Library of Medicine databases: the record it belongs to, who holds it, and any recall or enforcement report filed under it.

Sends only “K233732” to this site, which asks FDA and the National Library of Medicine. Nothing else on this page or in your Booking File is sent, and nothing is stored.

Your booking file

Record what you found

Did you see CoolSculpting Elite itself — the box, vial or device panel?

Your file lives in this browser. Recording waits until it has been read.