Dalphene Index

Devices linked to pigment & melasma

Derived area

26 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

Manufacturer22

Evidenceper modality

EU registerpresence only

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

26 products

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA211527
Approved2019Studies4,253Trials343

Sciton, Inc · Lasers & Light

510(k) · clearedClass IIK032460
Cleared2003Studies1,028Trials43

Solta Medical, Inc. · Lasers & Light

510(k) · clearedClass IIK223647EU
Cleared2011Studies1,157Trials128

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA020380
Approved1996Studies4,253Trials343

Quanta System Spa · Lasers & Light

510(k) · clearedClass IIK240983EU
Cleared2016Studies323Trials27

Cytrellis Biosystems, Inc. · RF & Microneedling

510(k) · clearedClass IIK252752
Cleared2025Studies619Trials135

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

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK243044
Cleared2008Studies1,028Trials43

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK142376EU
Cleared2011Studies1,028Trials43

Lutronic Global · Lasers & Light

510(k) · clearedClass IIK192331EU
Cleared2017Studies1,157Trials128

Eclipse Medcorp, LLC · RF & Microneedling

510(k) · clearedClass IIK212558
Cleared2021Studies619Trials135

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK212492EU
Cleared2015Studies1,028Trials43

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

Refine USA, LLC · RF & Microneedling

510(k) · clearedClass IIK192138
Cleared2020Studies619Trials135

VALEANT PHARMS NORTH · Skin & Topicals

NDA · approvedNDA021108
Approved2000Studies4,253Trials343

BAUSCH · Skin & Topicals

NDA · approvedNDA017340
Approved1973Studies4,253Trials343

Crown Aesthetics · RF & Microneedling

510(k) · clearedClass IIK241400EU
Cleared2018Studies619Trials135

Esthetic Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK253002
Cleared2020Studies619Trials135

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK250809EU
Cleared2015Studies1,028Trials43

ALMIRALL · Skin & Topicals

NDA · approvedNDA020600
Approved1997Studies4,253Trials343

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA021112
Approved2002Studies1,116Trials51

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 (26)
ProductMatched termSource string
AkliefmelasmaClinicalTrials.gov condition query for Topical retinoid
BBLpigmentationClinicalTrials.gov condition query for IPL / broadband light
Clear + BrilliantmelasmaClinicalTrials.gov condition query for Non-ablative fractional laser
DifferinmelasmaClinicalTrials.gov condition query for Topical retinoid
Discovery PicomelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
ellacormelasmaClinicalTrials.gov condition query for Mechanical microneedling
enlightenmelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
FraxmelasmaClinicalTrials.gov condition query for Non-ablative fractional laser
FraxelmelasmaClinicalTrials.gov condition query for Non-ablative fractional laser
Harmony XLpigmentationClinicalTrials.gov condition query for IPL / broadband light
IconpigmentationClinicalTrials.gov condition query for IPL / broadband light
LaseMDmelasmaClinicalTrials.gov condition query for Non-ablative fractional laser
MicroPen EVOmelasmaClinicalTrials.gov condition query for Mechanical microneedling
NordlyspigmentationClinicalTrials.gov condition query for IPL / broadband light
PicoCaremelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoPlusmelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoSuremelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
PicoWaymelasmaClinicalTrials.gov condition query for Picosecond laser (pigment & tattoo)
Rejuvapen NXTmelasmaClinicalTrials.gov condition query for Mechanical microneedling
RenovamelasmaClinicalTrials.gov condition query for Topical retinoid
Retin-AmelasmaClinicalTrials.gov condition query for Topical retinoid
SkinPenmelasmaClinicalTrials.gov condition query for Mechanical microneedling
SkinStylusmelasmaClinicalTrials.gov condition query for Mechanical microneedling
Stellar M22pigmentationClinicalTrials.gov condition query for IPL / broadband light
TazoracmelasmaClinicalTrials.gov condition query for Topical retinoid
Tri-LumamelasmaClinicalTrials.gov condition query for Topical hydroquinone / triple combination

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