Dalphene Index

Devices linked to photoaging & rejuvenation

Derived area

55 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

Manufacturer36

Evidenceper modality

EU registerpresence only

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

55 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

Sciton, Inc · Lasers & Light

510(k) · clearedClass IIK032460
Cleared2003Studies1,028Trials43

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

GALDERMA LABS LP · Skin & Topicals

NDA · approvedNDA020380
Approved1996Studies4,253Trials343

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

Alma Lasers, Inc. · Lasers & Light

510(k) · clearedClass IIK243044
Cleared2008Studies1,028Trials43

Maker · Skin & Topicals

Unverified mapping
DecisionStudies166Trials9

Cynosure, Inc. · Lasers & Light

510(k) · clearedClass IIK142376EU
Cleared2011Studies1,028Trials43

Lutronic Corporation · RF & Microneedling

510(k) · clearedClass IIK121481
Cleared2013Studies354Trials37

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK183284
Cleared2016Studies354Trials37

Maker · Injectables

No US authorization
DecisionStudies158Trials106

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

Candela Corporation · Lasers & Light

510(k) · clearedClass IIK212492EU
Cleared2015Studies1,028Trials43

Jeisys Medical, Inc. · RF & Microneedling

510(k) · clearedClass IIK231216EU
Cleared2020Studies354Trials37

Candela Corporation · RF & Microneedling

510(k) · clearedClass IIK240070
Cleared2016Studies354Trials37

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

BAUSCH · Skin & Topicals

NDA · approvedNDA017340
Approved1973Studies4,253Trials343

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

Sofwave Medical, Ltd. · Body Contouring

510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16

Fotona D.O.O. · Lasers & Light

510(k) · clearedClass IIK213267
Cleared2011Studies1,485Trials229

Lumenis Be, Ltd. · Lasers & Light

510(k) · clearedClass IIK250809EU
Cleared2015Studies1,028Trials43

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

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 (55)
ProductMatched termSource string
AcuPulsephotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
AestheFillphotoagingClinicalTrials.gov condition query for PDLLA / PLLA collagen biostimulator
Agnes RFrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
AkliefphotoagingClinicalTrials.gov condition query for Topical retinoid
Alma HybridphotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
ASCE+photoagingClinicalTrials.gov condition query for Exosome / extracellular-vesicle preparation
BBLphotoagingClinicalTrials.gov condition query for IPL / broadband light
CellREDMphotoagingClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
Clear + BrilliantphotoagingClinicalTrials.gov condition query for Non-ablative fractional laser
CO2REphotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
DifferinphotoagingClinicalTrials.gov condition query for Topical retinoid
eCO2photoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
ellacorrejuvenationClinicalTrials.gov condition query for Mechanical microneedling
Elravie Re2OphotoagingClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
EndyMed IntensifrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
FractorarejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
FraxphotoagingClinicalTrials.gov condition query for Non-ablative fractional laser
FraxelphotoagingClinicalTrials.gov condition query for Non-ablative fractional laser
GeniusrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
HalophotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Harmony XLphotoagingClinicalTrials.gov condition query for IPL / broadband light
HydraFacialphotoagingClinicalTrials.gov condition query for Hydradermabrasion
IconphotoagingClinicalTrials.gov condition query for IPL / broadband light
InfinirejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
INTRAcelrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
JuveacellphotoagingClinicalTrials.gov condition query for Human acellular dermal matrix (ECM) booster
LaseMDphotoagingClinicalTrials.gov condition query for Non-ablative fractional laser
MicroPen EVOrejuvenationClinicalTrials.gov condition query for Mechanical microneedling
Morpheus8rejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
NordlysphotoagingClinicalTrials.gov condition query for IPL / broadband light
PotenzarejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
ProfoundrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
RejuranphotoagingClinicalTrials.gov condition query for Polynucleotide (PDRN) skin booster
Rejuvapen NXTrejuvenationClinicalTrials.gov condition query for Mechanical microneedling
RenovaphotoagingClinicalTrials.gov condition query for Topical retinoid
Retin-AphotoagingClinicalTrials.gov condition query for Topical retinoid
Scarlet SRFrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
Secret ProrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
Secret RFrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
SkinPenrejuvenationClinicalTrials.gov condition query for Mechanical microneedling
SkinStylusrejuvenationClinicalTrials.gov condition query for Mechanical microneedling
SmartXidephotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
SofwaverejuvenationClinicalTrials.gov condition query for Ultrasound lifting & tightening
SP DynamisphotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Stellar M22photoagingClinicalTrials.gov condition query for IPL / broadband light
Sylfirm XrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
TazoracphotoagingClinicalTrials.gov condition query for Topical retinoid
TempSurerejuvenationClinicalTrials.gov condition query for Monopolar RF skin tightening
ThermagerejuvenationClinicalTrials.gov condition query for Monopolar RF skin tightening
UltherapyrejuvenationClinicalTrials.gov condition query for Ultrasound lifting & tightening
UltraPulsephotoagingClinicalTrials.gov condition query for Ablative / hybrid fractional laser
Venus VivarejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
VirtueRFrejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
VivacerejuvenationClinicalTrials.gov condition query for Radiofrequency microneedling
VolnewmerrejuvenationClinicalTrials.gov condition query for Monopolar RF skin tightening

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