Dalphene Index

Devices linked to fat & body contouring

Derived area

16 products · matched by keyword rule, not the cleared indication

Filters

Category

FDA pathwayCleared vs approvedCleared means the FDA agreed a device resembles one already on sale, while approved means the FDA read the maker's own clinical evidence and accepted it, so the two words describe different amounts of review and are not interchangeable.510(k) = cleared

Manufacturer12

Evidenceper modality

EU registerpresence only

Narrows to products we matched in EUDAMED. There is no opposite filter.

16 products

Alma Lasers, Inc. · Body Contouring

510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0

Biophotas, Inc. · Lasers & Light

510(k) · clearedClass IIK232977EU
Cleared2014StudiesTrials

Zeltiq Aesthetics, Inc. · Body Contouring

510(k) · clearedClass IIK193566
Cleared2012Studies245Trials20

Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · Body Contouring

510(k) · clearedClass IIK233732EU
Cleared2021Studies245Trials20

Zimmer Medizinsysteme GmbH · Body Contouring

510(k) · clearedClass IIK253408
Cleared2019Studies61Trials4

Erchonia Corporation · Body Contouring

510(k) · clearedClass IIK192544
Cleared2020Studies112Trials0

Maker · Body Contouring

Unverified mapping
DecisionStudies61Trials4

BTL Industries, Inc. · Body Contouring

510(k) · clearedClass IIK163176
Cleared2009Studies255Trials0

Bios S.R.L. · Body Contouring

510(k) · clearedClass IIK230755EU
Cleared2020Studies255Trials0

Cynosure · Body Contouring

510(k) · clearedClass IIK182741
Cleared2015Studies112Trials0

Cutera, Inc. · Body Contouring

510(k) · clearedClass IIK180709EU
Cleared2012Studies255Trials0

Cutera, Inc. · Body Contouring

510(k) · clearedClass IIK223110EU
Cleared2022Studies255Trials0

Syneron Medical, Ltd. · Body Contouring

510(k) · clearedClass IIK122579
Cleared2007Studies255Trials0

Venus Concept USA, Inc. · Body Contouring

510(k) · clearedClass IIK220592
Cleared2019Studies112Trials0

Venus Concept USA, Inc. · Body Contouring

510(k) · clearedClass IIK191528
Cleared2015Studies255Trials0

Erchonia Corporation · Body Contouring

510(k) · clearedClass IIK243811
Cleared2012Studies112Trials0

Curated seed list; study and trial counts are per modality, not per brand.

Sorted by most recent FDA decision — a filing date, not a quality signal.

How each product matched (16)
ProductMatched termSource string
Accentbody contouringClinicalTrials.gov condition query for RF body contouring
Cellumafat reducFDA product code OLI — Fat Reducing Low Level Laser
CoolSculptingbody contouringClinicalTrials.gov condition query for Cryolipolysis
CoolSculpting Elitebody contouringClinicalTrials.gov condition query for Cryolipolysis
CoolTonebody contouringClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation
Emerald Laserbody contouringClinicalTrials.gov condition query for Non-invasive laser lipolysis
Emsculpt NEObody contouringClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation
Exilisbody contouringClinicalTrials.gov condition query for RF body contouring
NuEra Tightbody contouringClinicalTrials.gov condition query for RF body contouring
SculpSurebody contouringClinicalTrials.gov condition query for Non-invasive laser lipolysis
truSculptbody contouringClinicalTrials.gov condition query for RF body contouring
truSculpt iDbody contouringClinicalTrials.gov condition query for RF body contouring
VelaShapebody contouringClinicalTrials.gov condition query for RF body contouring
Venus Blissbody contouringClinicalTrials.gov condition query for Non-invasive laser lipolysis
Venus Legacybody contouringClinicalTrials.gov condition query for RF body contouring
Zeronabody contouringClinicalTrials.gov condition query for Non-invasive laser lipolysis

Derived by keyword rule from real source strings, not the cleared indication.