Dalphene Index

CoolSculpting is one of 2 cryolipolysis devices in this Index

Updated Jul 25 2026

Cryolipolysis · 2 indexed products · Body Contouring

CoolSculpting is not an alternative to cryolipolysis — it is one implementation of it. This Index groups it under cryolipolysis, together with 1 other device. CoolSculpting (Zeltiq Aesthetics, Inc.) is FDA cleared under a 510(k): record K193566, first cleared May 2 2012, 11 FDA records in all, the most recent Jan 21 2020. The published evidence for the technique — 245 papers on PubMed, 20 registered on ClinicalTrials.gov — belongs to both of them, not to any one brand. Every one of them carries an FDA record matched here, cleared under it.

The short name drops words from this Index's modality id — it never adds one.

What the FDA record says about CoolSculpting

Pathway510(k) · cleared
IdentifierK193566
First decision
FDA records matched11

A 510(k) device is cleared, not approved — a different route, not a lesser one.

Full record for CoolSculpting, every identifier and every source query →

What cryolipolysis is, as this Index counts it

Cryolipolysis

Papers (PubMed)245
Papers, last 10 yr199
Trials registered20
Trials recruiting0

Counted for the technique, from one fixed query the brand name is not in.

The 1 other cryolipolysis device in this Index

Every product this Index groups under this technique, with the FDA record matched to its brand name. Copied from the public record; an unknown is an em-dash carrying its reason. The order is alphabetical and carries no meaning.
ProductApplicant of recordPathwayFirst decisionIdentifier
CoolSculpting this pageZeltiq Aesthetics, Inc.510(k) · clearedK193566
CoolSculpting EliteZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics510(k) · clearedK233732

Why every product above shows the same study count

Study and trial figures on this site are counted per TECHNIQUE, never per brand. One fixed query is run for the modality and the brand name appears nowhere inside it, so every product that shares a technique carries exactly the same number. That identical figure is EXPECTED and it is not a claim about either product: it is not a finding that they are equivalent, not a measurement of either one, and not evidence that one works as well as the other. It is a fact about the published literature and nothing else. Brand-name literature searches were rejected for the opposite reason — they reward the manufacturer with the larger marketing department and punish an equally well-built product with a quieter name.

Nearby comparisons

Which pairs exist is editorial — observed search demand, not a judgement about any product.

Assembled by a program from public records; no figure here was written by hand.