Dalphene Index

Devices linked to scars

Derived area

41 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

Manufacturer31

Evidenceper modality

EU registerpresence only

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

41 products

Lumenis, Ltd. · Lasers & Light

510(k) · clearedClass IIK212703EU
Cleared2008Studies1,485Trials229

Agnes Medical Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK250217
Cleared2017Studies354Trials37

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK251230EU
Cleared2021Studies1,485Trials229

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

Quanta System Spa · Lasers & Light

510(k) · clearedClass IIK240983EU
Cleared2016Studies323Trials27

Lutronic Corporation · Lasers & Light

510(k) · clearedClass IIK244060
Cleared2008Studies1,485Trials229

Cytrellis Biosystems, Inc. · RF & Microneedling

510(k) · clearedClass IIK252752
Cleared2025Studies619Trials135

Endymed Medical, Ltd. · RF & Microneedling

510(k) · clearedClass IIK130501
Cleared2014Studies354Trials37

Cutera, Inc. · Lasers & Light

510(k) · clearedClass IIK182997EU
Cleared2016Studies323Trials27

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

Lutronic Global · Lasers & Light

510(k) · clearedClass IIK192331EU
Cleared2017Studies1,157Trials128

Eclipse Medcorp, LLC · RF & Microneedling

510(k) · clearedClass IIK212558
Cleared2021Studies619Trials135

InMode , Ltd. · RF & Microneedling

510(k) · clearedClass IIK240017EU
Cleared2019Studies354Trials37

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

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

El.En S.P.A. · Lasers & Light

510(k) · clearedClass IIK240537EU
Cleared2003Studies1,485Trials229

Fotona D.O.O. · Lasers & Light

510(k) · clearedClass IIK213267
Cleared2011Studies1,485Trials229

VIOL Co., Ltd. · RF & Microneedling

510(k) · clearedClass IIK213612EU
Cleared2020Studies354Trials37

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK233301EU
Cleared1991Studies1,485Trials229

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK230990EU
Cleared2002Studies1,530Trials72

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

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 (41)
ProductMatched termSource string
AcuPulsescarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Agnes RFscarClinicalTrials.gov condition query for Radiofrequency microneedling
Alma HybridscarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Clear + BrilliantscarClinicalTrials.gov condition query for Non-ablative fractional laser
CO2REscarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
CynergyscarClinicalTrials.gov condition query for Pulsed dye laser
Discovery PicoscarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
eCO2scarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
ellacorscarClinicalTrials.gov condition query for Mechanical microneedling
EndyMed IntensifscarClinicalTrials.gov condition query for Radiofrequency microneedling
enlightenscarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
FractorascarClinicalTrials.gov condition query for Radiofrequency microneedling
FraxscarClinicalTrials.gov condition query for Non-ablative fractional laser
FraxelscarClinicalTrials.gov condition query for Non-ablative fractional laser
GeniusscarClinicalTrials.gov condition query for Radiofrequency microneedling
HaloscarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
InfiniscarClinicalTrials.gov condition query for Radiofrequency microneedling
INTRAcelscarClinicalTrials.gov condition query for Radiofrequency microneedling
LaseMDscarClinicalTrials.gov condition query for Non-ablative fractional laser
MicroPen EVOscarClinicalTrials.gov condition query for Mechanical microneedling
Morpheus8scarClinicalTrials.gov condition query for Radiofrequency microneedling
PicoCarescarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoPlusscarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoSurescarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoWayscarClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PotenzascarClinicalTrials.gov condition query for Radiofrequency microneedling
ProfoundscarClinicalTrials.gov condition query for Radiofrequency microneedling
Rejuvapen NXTscarClinicalTrials.gov condition query for Mechanical microneedling
Scarlet SRFscarClinicalTrials.gov condition query for Radiofrequency microneedling
Secret ProscarClinicalTrials.gov condition query for Radiofrequency microneedling
Secret RFscarClinicalTrials.gov condition query for Radiofrequency microneedling
SkinPenscarClinicalTrials.gov condition query for Mechanical microneedling
SkinStylusscarClinicalTrials.gov condition query for Mechanical microneedling
SmartXidescarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
SP DynamisscarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Sylfirm XscarClinicalTrials.gov condition query for Radiofrequency microneedling
UltraPulsescarClinicalTrials.gov condition query for Ablative / hybrid fractional laser
VbeamscarClinicalTrials.gov condition query for Pulsed dye laser
Venus VivascarClinicalTrials.gov condition query for Radiofrequency microneedling
VirtueRFscarClinicalTrials.gov condition query for Radiofrequency microneedling
VivacescarClinicalTrials.gov condition query for Radiofrequency microneedling

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