Dalphene Index

136 aesthetic modalities, checked against the FDA record

Compare products + Missing a device? Updated Jul 25 2026

136 products · 125 matched to an FDA record · 8 with no US authorization found · 3 unmatched, shown as — · tick the corner box on any card to compare

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

Manufacturer75

Treatment areaderived

Evidenceper modality

EU registerpresence only

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

136 products

Alma Lasers, Inc. · Body Contouring

510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0

Revelle Aesthetics, Inc. · Body Contouring

510(k) · clearedClass IIK232153
Cleared2022Studies50Trials4

Ulthera, Inc. · Body Contouring

510(k) · clearedClass IIK192185
Cleared2015Studies50Trials4

Cynosure, Inc. · Body Contouring

510(k) · clearedClass IIK123407EU
Cleared2012Studies50Trials4

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

Sofwave Medical, Ltd. · Body Contouring

510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16

Cutera, Inc. · Body Contouring

510(k) · clearedClass IIK180709EU
Cleared2012Studies255Trials0

Johari Digital Healthcare Limited · Body Contouring

510(k) · clearedClass IIK212866
Cleared2022StudiesTrials

Cutera, Inc. · Body Contouring

510(k) · clearedClass IIK223110EU
Cleared2022Studies255Trials0

Ulthera, Inc. · Body Contouring

510(k) · clearedClass IIK260618
Cleared2009Studies317Trials16

Syneron Medical, Ltd. · Body Contouring

510(k) · clearedClass IIK170370
Cleared2014StudiesTrials

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

Maker · Injectables

No US authorization
DecisionStudies450Trials49

Maker · Injectables

No US authorization
DecisionStudies2,396Trials79

Tiger Aesthetics Medical, LLC · Injectables

PMA · approvedP020012
Approved2006StudiesTrials

Merz North America, Inc. · Injectables

PMA · approvedP090016
Approved2011Studies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP250016
Approved2026Studies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP250020
Approved2026Studies1,298Trials46

ALLERGAN · Injectables

BLA · approvedBLA103000
Approved1991Studies2,201Trials186

Maker · Injectables

No US authorization
DecisionStudies158Trials106

REVANCE THERAPEUTICS, INC. · Injectables

BLA · approvedBLA761127
Approved2022Studies2,201Trials186

IPSEN BIOPHARM LTD · Injectables

BLA · approvedBLA125274
Approved2009Studies2,201Trials186

Maker · Injectables

No US authorization
DecisionStudiesTrials

Maker · Injectables

No US authorization
DecisionStudies158Trials106

HALOZYME THERAP · Injectables

BLA · approvedBLA021859
Approved2005StudiesTrials

EVOLUS INC · Injectables

BLA · approvedBLA761085
Approved2019Studies2,201Trials186

Maker · Injectables

No US authorization
DecisionStudies158Trials106

Allergan · Injectables

PMA · approvedP050047
Approved2010Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2016Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2017Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2013Studies1,298Trials46

Allergan · Injectables

PMA · approvedP110033
Approved2022Studies1,298Trials46

ABBVIE · Injectables

NDA · approvedNDA206333
Approved2015StudiesTrials

HUGEL INC · Injectables

BLA · approvedBLA761225
Approved2024Studies2,201Trials186

Maker · Injectables

No US authorization
DecisionStudies1,298Trials46

Merz North America, Inc. · Injectables

PMA · approvedP050037
Approved2006Studies582Trials7

Maker · Injectables

No US authorization
DecisionStudies155Trials16

Q-Med AB · Injectables

PMA · approvedP140029EU
Approved2016Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP140029EU
Approved2020Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP040024EU
Approved2015Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP040024
Approved2014Studies1,298Trials46

Prollenium Medical Technologies, Inc. · Injectables

PMA · approvedP160042
Approved2017Studies1,298Trials46

Teoxane S.A. · Injectables

PMA · approvedP170002
Approved2017Studies1,298Trials46

Q-Med AB · Injectables

PMA · approvedP030050EU
Approved2004Studies586Trials17

Allergan · Injectables

PMA · approvedP110033
Approved2023Studies1,298Trials46

MERZ PHARMS · Injectables

BLA · approvedBLA125360
Approved2010Studies2,201Trials186

Accure Acne, Inc. · Lasers & Light

510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5

Lumenis, Ltd. · Lasers & Light

510(k) · clearedClass IIK212703EU
Cleared2008Studies1,485Trials229

Aerolase Medical Lasers, LLC · Lasers & Light

510(k) · clearedClass IIK120235
Cleared2012StudiesTrials

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK251230EU
Cleared2021Studies1,485Trials229

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK034030
Cleared2000Studies744Trials30

Cutera, Inc. · Lasers & Light

510(k) · clearedClass IIK251149EU
Cleared2022Studies66Trials5

Sciton, Inc · Lasers & Light

510(k) · clearedClass IIK032460
Cleared2003Studies1,028Trials43

Sun Pharmaceutical Industries, Inc. · Lasers & Light

510(k) · clearedClass IIK241358
Cleared2003StudiesTrials

Biophotas, Inc. · Lasers & Light

510(k) · clearedClass IIK232977EU
Cleared2014StudiesTrials

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK183566EU
Cleared2013Studies744Trials30

Solta Medical, Inc. · Lasers & Light

510(k) · clearedClass IIK223647EU
Cleared2011Studies1,157Trials128

Syneron-Candela Corp · Lasers & Light

510(k) · clearedClass IIK181523
Cleared2015Studies1,485Trials229

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK050779EU
Cleared2005Studies1,530Trials72

Inmode MD , Ltd. · Lasers & Light

510(k) · clearedClass IIK180719
Cleared2015Studies744Trials30

Quanta System Spa · Lasers & Light

510(k) · clearedClass IIK240983EU
Cleared2016Studies323Trials27

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK244060
Cleared2008Studies1,485Trials229

Cynosure, LLC · Lasers & Light

510(k) · clearedClass IIK240396
Cleared2020Studies744Trials30

Cutera, Inc. · Lasers & Light

510(k) · clearedClass IIK182997EU
Cleared2016Studies323Trials27

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK212492EU
Cleared2016Studies1,157Trials128

Solta Medical · Lasers & Light

510(k) · clearedClass IIK242142EU
Cleared2005Studies1,157Trials128

Candela Corp. · Lasers & Light

510(k) · clearedClass IIK140732EU
Cleared1997Studies744Trials30

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK201111EU
Cleared2011Studies744Trials30

Maker · Lasers & Light

Unverified mapping
DecisionStudies1,485Trials229

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK243044
Cleared2008Studies1,028Trials43

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK213569EU
Cleared2007StudiesTrials

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK142376EU
Cleared2011Studies1,028Trials43

Lutronic Global · Lasers & Light

510(k) · clearedClass IIK192331EU
Cleared2017Studies1,157Trials128

Lumenis, Ltd. · Lasers & Light

510(k) · clearedClass IIK170179EU
Cleared1998Studies744Trials30

Led Intellectual Properties, LLC · Lasers & Light

510(k) · clearedClass IIK212771EU
Cleared2010StudiesTrials

El.En S.P.A. · Lasers & Light

510(k) · clearedClass IIK241459EU
Cleared2017Studies744Trials30

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK212492EU
Cleared2015Studies1,028Trials43

Globalmed Technologies · Lasers & Light

510(k) · clearedClass IIK210948
Cleared2003StudiesTrials

Wontech Co., Ltd. · Lasers & Light

510(k) · clearedClass IIK181272
Cleared2017Studies323Trials27

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK173700
Cleared2018Studies323Trials27

Cynosure, LLC · Lasers & Light

510(k) · clearedClass IIK261570EU
Cleared2012Studies323Trials27

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK220853EU
Cleared2015Studies323Trials27

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK133254EU
Cleared2006StudiesTrials

El.En S.P.A. · Lasers & Light

510(k) · clearedClass IIK240537EU
Cleared2003Studies1,485Trials229

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK230371EU
Cleared2009Studies744Trials30

Fotona D.O.O. · Lasers & Light

510(k) · clearedClass IIK213267
Cleared2011Studies1,485Trials229

Bios S.R.L. · Lasers & Light

510(k) · clearedClass IIK243445EU
Cleared2024Studies744Trials30

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK250809EU
Cleared2015Studies1,028Trials43

Jeisys Medical Incorporated · Lasers & Light

510(k) · clearedClass IIK251464
Cleared2025StudiesTrials

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK233301EU
Cleared1991Studies1,485Trials229

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK230990EU
Cleared2002Studies1,530Trials72

Palomar Medical Technologies, Inc. · Lasers & Light

510(k) · clearedClass IIK120622EU
Cleared2012Studies744Trials30

Agnes Medical Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK250217
Cleared2017Studies354Trials37

Cytrellis Biosystems, Inc. · RF & Microneedling

510(k) · clearedClass IIK252752
Cleared2025Studies619Trials135

Endymed Medical, Ltd. · RF & Microneedling

510(k) · clearedClass IIK130501
Cleared2014Studies354Trials37

Invasix , Ltd. · RF & Microneedling

510(k) · clearedClass IIK102461
Cleared2011Studies354Trials37

Cynosure Lutronic Technology Corporation · RF & Microneedling

510(k) · clearedClass IIK253484EU
Cleared2018Studies354Trials37

Lutronic Corporation · RF & Microneedling

510(k) · clearedClass IIK121481
Cleared2013Studies354Trials37

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK183284
Cleared2016Studies354Trials37

Eclipse Medcorp, LLC · RF & Microneedling

510(k) · clearedClass IIK212558
Cleared2021Studies619Trials135

InMode , Ltd. · RF & Microneedling

510(k) · clearedClass IIK240017EU
Cleared2019Studies354Trials37

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK231216EU
Cleared2020Studies354Trials37

Candela Corporation · RF & Microneedling

510(k) · clearedClass IIK240070
Cleared2016Studies354Trials37

Refine USA, LLC · RF & Microneedling

510(k) · clearedClass IIK192138
Cleared2020Studies619Trials135

VIOL Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK180872
Cleared2018Studies354Trials37

Ilooda Co,., Ltd. · RF & Microneedling

510(k) · clearedClass IIK233374
Cleared2023Studies354Trials37

Ilooda Co,., Ltd. · RF & Microneedling

510(k) · clearedClass IIK182355
Cleared2017Studies354Trials37

Crown Aesthetics · RF & Microneedling

510(k) · clearedClass IIK241400EU
Cleared2018Studies619Trials135

Esthetic Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK253002
Cleared2020Studies619Trials135

VIOL Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK213612EU
Cleared2020Studies354Trials37

Cynosure, LLC · RF & Microneedling

510(k) · clearedClass IIK223292EU
Cleared2017Studies432Trials9

Solta Medical · RF & Microneedling

510(k) · clearedClass IIK173759EU
Cleared2000Studies432Trials9

Venus Concept USA, Inc. · RF & Microneedling

510(k) · clearedClass IIK201164
Cleared2015Studies354Trials37

ShenB Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK211562
Cleared2021Studies354Trials37

ShenB Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK193070EU
Cleared2016Studies354Trials37

Classys, Inc. · RF & Microneedling

510(k) · clearedClass IIK240248EU
Cleared2024Studies432Trials9

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA211527
Approved2019Studies4,253Trials343

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA020380
Approved1996Studies4,253Trials343

Maker · Skin & Topicals

Unverified mapping
DecisionStudies166Trials9

ABBVIE · Skin & Topicals

NDA · approvedNDA022369
Approved2008Studies128Trials28

VALEANT PHARMS NORTH · Skin & Topicals

NDA · approvedNDA021108
Approved2000Studies4,253Trials343

BAUSCH · Skin & Topicals

NDA · approvedNDA017340
Approved1973Studies4,253Trials343

KENVUE BRANDS · Skin & Topicals

NDA · approvedNDA019501
Approved1988StudiesTrials

ALMIRALL · Skin & Topicals

NDA · approvedNDA020600
Approved1997Studies4,253Trials343

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA021112
Approved2002Studies1,116Trials51

SUN PHARM · Skin & Topicals

NDA · approvedNDA213433
Approved2020Studies90Trials21

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.