Dalphene Index

CoolTone is one of 2 muscle stimulation devices in this Index

Updated Jul 25 2026

High-intensity electromagnetic muscle stimulation · 2 indexed products · Body Contouring

CoolTone is not an alternative to muscle stimulation — it is one implementation of it. This Index groups it under high-intensity electromagnetic muscle stimulation, together with 1 other device. CoolTone (Zimmer Medizinsysteme GmbH) is FDA cleared under a 510(k): record K253408, first cleared Nov 15 2019, 4 FDA records in all, the most recent Jan 16 2026. The published evidence for the technique — 61 papers on PubMed, 4 registered on ClinicalTrials.gov — belongs to both of them, not to any one brand. 1 of the 2 carry 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 CoolTone

Pathway510(k) · cleared
IdentifierK253408
First decision
FDA records matched4

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

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

What muscle stimulation is, as this Index counts it

High-intensity electromagnetic muscle stimulation

Papers (PubMed)61
Papers, last 10 yr61
Trials registered4
Trials recruiting0

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

The 1 other muscle stimulation 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
CoolTone this pageZimmer Medizinsysteme GmbH510(k) · clearedK253408
Emsculpt NEOUnverified mapping

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.