Dalphene Index

Ultherapy is one of 2 ultrasound skin tightening devices in this Index

Updated Jul 25 2026

Ultrasound lifting & tightening · 2 indexed products · Body Contouring

Ultherapy is not an alternative to ultrasound skin tightening — it is one implementation of it. This Index groups it under ultrasound lifting & tightening, together with 1 other device. Ultherapy (Ulthera, Inc.) is FDA cleared under a 510(k): record K260618, first cleared Sep 11 2009, 10 FDA records in all, the most recent May 21 2026. The published evidence for the technique — 317 papers on PubMed, 16 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 Ultherapy

Pathway510(k) · cleared
IdentifierK260618
First decision
FDA records matched10

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

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

What ultrasound skin tightening is, as this Index counts it

Ultrasound lifting & tightening

Papers (PubMed)317
Papers, last 10 yr261
Trials registered16
Trials recruiting1

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

The 1 other ultrasound skin tightening 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
SofwaveSofwave Medical, Ltd.510(k) · clearedK250146
Ultherapy this pageUlthera, Inc.510(k) · clearedK260618

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.