Dalphene Index

Devices linked to wrinkles & lines

Derived area

75 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

Manufacturer47

Evidenceper modality

EU registerpresence only

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

75 products

Lumenis, Ltd. · Lasers & Light

510(k) · clearedClass IIK212703EU
Cleared2008Studies1,485Trials229

Maker · Injectables

No US authorization
DecisionStudies450Trials49

Agnes Medical Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK250217
Cleared2017Studies354Trials37

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA211527
Approved2019Studies4,253Trials343

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK251230EU
Cleared2021Studies1,485Trials229

Maker · Injectables

No US authorization
DecisionStudies2,396Trials79

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

Solta Medical, Inc. · Lasers & Light

510(k) · clearedClass IIK223647EU
Cleared2011Studies1,157Trials128

Syneron-Candela Corp · Lasers & Light

510(k) · clearedClass IIK181523
Cleared2015Studies1,485Trials229

REVANCE THERAPEUTICS, INC. · Injectables

BLA · approvedBLA761127
Approved2022Studies2,201Trials186

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA020380
Approved1996Studies4,253Trials343

IPSEN BIOPHARM LTD · Injectables

BLA · approvedBLA125274
Approved2009Studies2,201Trials186

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK244060
Cleared2008Studies1,485Trials229

Cytrellis Biosystems, Inc. · RF & Microneedling

510(k) · clearedClass IIK252752
Cleared2025Studies619Trials135

Maker · Injectables

No US authorization
DecisionStudies158Trials106

Endymed Medical, Ltd. · RF & Microneedling

510(k) · clearedClass IIK130501
Cleared2014Studies354Trials37

Invasix , Ltd. · RF & Microneedling

510(k) · clearedClass IIK102461
Cleared2011Studies354Trials37

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK212492EU
Cleared2016Studies1,157Trials128

Solta Medical · Lasers & Light

510(k) · clearedClass IIK242142EU
Cleared2005Studies1,157Trials128

Cynosure Lutronic Technology Corporation · RF & Microneedling

510(k) · clearedClass IIK253484EU
Cleared2018Studies354Trials37

Maker · Lasers & Light

Unverified mapping
DecisionStudies1,485Trials229

Lutronic Corporation · RF & Microneedling

510(k) · clearedClass IIK121481
Cleared2013Studies354Trials37

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK183284
Cleared2016Studies354Trials37

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

Lutronic Global · Lasers & Light

510(k) · clearedClass IIK192331EU
Cleared2017Studies1,157Trials128

HUGEL INC · Injectables

BLA · approvedBLA761225
Approved2024Studies2,201Trials186

Led Intellectual Properties, LLC · Lasers & Light

510(k) · clearedClass IIK212771EU
Cleared2010StudiesTrials

Eclipse Medcorp, LLC · RF & Microneedling

510(k) · clearedClass IIK212558
Cleared2021Studies619Trials135

InMode , Ltd. · RF & Microneedling

510(k) · clearedClass IIK240017EU
Cleared2019Studies354Trials37

Globalmed Technologies · Lasers & Light

510(k) · clearedClass IIK210948
Cleared2003StudiesTrials

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK231216EU
Cleared2020Studies354Trials37

Maker · Injectables

No US authorization
DecisionStudies1,298Trials46

Candela Corporation · RF & Microneedling

510(k) · clearedClass IIK240070
Cleared2016Studies354Trials37

Merz North America, Inc. · Injectables

PMA · approvedP050037
Approved2006Studies582Trials7

Maker · Injectables

No US authorization
DecisionStudies155Trials16

Refine USA, LLC · RF & Microneedling

510(k) · clearedClass IIK192138
Cleared2020Studies619Trials135

VALEANT PHARMS NORTH · Skin & Topicals

NDA · approvedNDA021108
Approved2000Studies4,253Trials343

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

BAUSCH · Skin & Topicals

NDA · approvedNDA017340
Approved1973Studies4,253Trials343

Prollenium Medical Technologies, Inc. · Injectables

PMA · approvedP160042
Approved2017Studies1,298Trials46

Teoxane S.A. · Injectables

PMA · approvedP170002
Approved2017Studies1,298Trials46

VIOL Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK180872
Cleared2018Studies354Trials37

Q-Med AB · Injectables

PMA · approvedP030050EU
Approved2004Studies586Trials17

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

Allergan · Injectables

PMA · approvedP110033
Approved2023Studies1,298Trials46

El.En S.P.A. · Lasers & Light

510(k) · clearedClass IIK240537EU
Cleared2003Studies1,485Trials229

Sofwave Medical, Ltd. · Body Contouring

510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16

Fotona D.O.O. · Lasers & Light

510(k) · clearedClass IIK213267
Cleared2011Studies1,485Trials229

VIOL Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK213612EU
Cleared2020Studies354Trials37

ALMIRALL · Skin & Topicals

NDA · approvedNDA020600
Approved1997Studies4,253Trials343

Cynosure, LLC · RF & Microneedling

510(k) · clearedClass IIK223292EU
Cleared2017Studies432Trials9

Solta Medical · RF & Microneedling

510(k) · clearedClass IIK173759EU
Cleared2000Studies432Trials9

Ulthera, Inc. · Body Contouring

510(k) · clearedClass IIK260618
Cleared2009Studies317Trials16

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK233301EU
Cleared1991Studies1,485Trials229

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

MERZ PHARMS · Injectables

BLA · approvedBLA125360
Approved2010Studies2,201Trials186

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 (75)
ProductMatched termSource string
AcuPulsewrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
AestheFillwrinkleClinicalTrials.gov condition query for PDLLA / PLLA collagen biostimulator
Agnes RFwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
AkliefwrinkleClinicalTrials.gov condition query for Topical retinoid
Alma HybridwrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
ASCE+wrinkleClinicalTrials.gov condition query for Exosome / extracellular-vesicle preparation
Belotero BalancewrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Belotero Intense (+) LidocainewrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Belotero Volume (+) LidocainewrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Botox CosmeticwrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)
CellREDMwrinkleClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
Clear + BrilliantwrinkleClinicalTrials.gov condition query for Non-ablative fractional laser
CO2REwrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
DaxxifywrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)
DifferinwrinkleClinicalTrials.gov condition query for Topical retinoid
DysportwrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)
eCO2wrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
ellacorwrinkleClinicalTrials.gov condition query for Mechanical microneedling
Elravie Re2OwrinkleClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
EndyMed IntensifwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
FractorawrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
FraxwrinkleClinicalTrials.gov condition query for Non-ablative fractional laser
FraxelwrinkleClinicalTrials.gov condition query for Non-ablative fractional laser
GeniuswrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
HalowrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
InfiniwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
INTRAcelwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
JeuveauwrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)
JuveacellwrinkleClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
Juvederm Ultra XCwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Volbella XCwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Vollure XCwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Voluma XCwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Juvederm Volux XCwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
LaseMDwrinkleClinicalTrials.gov condition query for Non-ablative fractional laser
LetybowrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)
LightStimwrinkleFDA product code OHS — Light Based Over The Counter Wrinkle Reduction
MicroPen EVOwrinkleClinicalTrials.gov condition query for Mechanical microneedling
Morpheus8wrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
OmniluxwrinkleFDA product code OHS — Light Based Over The Counter Wrinkle Reduction
PotenzawrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
ProfhilowrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
ProfoundwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
RadiessewrinkleClinicalTrials.gov condition query for Calcium hydroxylapatite filler
RejuranwrinkleClinicalTrials.gov condition query for Polynucleotide (PDRN) skin booster
Rejuvapen NXTwrinkleClinicalTrials.gov condition query for Mechanical microneedling
RenovawrinkleClinicalTrials.gov condition query for Topical retinoid
Restylane DefynewrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane KyssewrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane LyftwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Restylane SilkwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Retin-AwrinkleClinicalTrials.gov condition query for Topical retinoid
Revanesse VersawrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
RHA CollectionwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
Scarlet SRFwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
SculptrawrinkleClinicalTrials.gov condition query for Poly-L-lactic acid collagen stimulator
Secret ProwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
Secret RFwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
SkinPenwrinkleClinicalTrials.gov condition query for Mechanical microneedling
SkinStyluswrinkleClinicalTrials.gov condition query for Mechanical microneedling
SKINVIVE by JuvedermwrinkleClinicalTrials.gov condition query for Hyaluronic acid filler
SmartXidewrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
SofwavewrinkleClinicalTrials.gov condition query for Ultrasound lifting & tightening
SP DynamiswrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Sylfirm XwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
TazoracwrinkleClinicalTrials.gov condition query for Topical retinoid
TempSurewrinkleClinicalTrials.gov condition query for Monopolar RF skin tightening
ThermagewrinkleClinicalTrials.gov condition query for Monopolar RF skin tightening
UltherapywrinkleClinicalTrials.gov condition query for Ultrasound lifting & tightening
UltraPulsewrinkleClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Venus VivawrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
VirtueRFwrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
VivacewrinkleClinicalTrials.gov condition query for Radiofrequency microneedling
VolnewmerwrinkleClinicalTrials.gov condition query for Monopolar RF skin tightening
XeominwrinkleClinicalTrials.gov condition query for Botulinum toxin (cosmetic)

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