Dalphene Index

Aesthetic device rankings, from public records

Updated Jul 26, 2026

Proxy signals from openFDA, PubMed and ClinicalTrials.gov.

Nothing here ranks how well a treatment works: 510(k) devices are cleared, not approved.

93Narrow-codeNarrow codesThe FDA device codes on this site that describe unmistakably aesthetic equipment, so counts built from them leave out general-purpose surgical kit. clearances, 365 days
18In the last 90 days
136Devices indexed125 crosswalkedCrosswalkThe mapping this site keeps between records that no single source links up, such as tying a brand name to the FDA codes and the study searches that describe the same thing. to FDA records
29ModalitiesModalityA family of treatments that work the same way — such as radiofrequency microneedling, or lasers that leave the skin surface intact — rather than any one branded machine. tracked

Research attention, 2016–2026

method →See more
1,786papers · 2025

papers per year · 2016–2026 · 2026 partial

Papers a year rose 120% between 2016 and 2025, from 813 to 1,786; Injectables added the most (up 493 papers) and Body Contouring the least (up 59).

05001,0001,5002,000InjectablesLasers & Light201620182020202220242026

Values and shares are 2025, the latest full year.

PubMed papers per year by category, 2016–2026 (2026 partial)
Lasers & LightInjectablesBody ContouringSkin & TopicalsRF & MicroneedlingTotal
20163371647217961813
20173071826317355780
20183342007015467825
20193432196319392910
2020403314812111151,124
2021447309842391341,213
2022404320912271541,196
20233603591222321291,202
2024398499972661731,433
20255036571312692261,786
2026311431471901491,128

PubMed records per year matching our fixed treatment queries — publication volume, not quality, efficacy or market share.

New this month

4 narrow-code clearances in 30 daysmethod →See more

Each card: the FDA decision date, the device name as the record spells it, then the applicant and category. The mono-spaced pill is the K-numberK-numberThe reference the FDA stamps on a 510(k) submission, written like K123456, which is how you pull up the exact record for a device. of that 510(k) — cleared, not approved — and it opens the record on openFDAopenFDAThe FDA's own public data service, which is where every clearance record on this site comes from..

  • Jul 10, 2026Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.RF & MicroneedlingK253480
  • Jul 1, 2026ChromixTermosalud S.L.Lasers & LightK261473
  • Jun 29, 2026LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.Lasers & LightK261052
  • Jun 26, 2026Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.Lasers & LightK261253

The newest 510(k) decisions in unambiguously aesthetic codes — 4 cards because there were 4.

Research momentum

top 10 of 25 modalities · shared scalemethod →See more

Each card draws PubMedPubMedThe United States National Library of Medicine's index of published medical literature, which is where this site's paper counts come from. records a year for one treatment, 2016 to 2026. The large figure is 2025, the last full year; the pill beside it is the change against 2024. The final point of every line is the partial current year and is drawn hollow.

Botulinum toxin (cosmetic) — PubMed papers per year, 2016–2026 (2026 partial)
Botulinum toxin (cosmetic)
201687
201786
201887
2019105
2020137
2021129
2022140
2023151
2024206
2025258
2026177
258+25%
Hyaluronic acid filler — PubMed papers per year, 2016–2026 (2026 partial)
Hyaluronic acid filler
201644
201755
201864
201980
2020110
2021119
2022114
2023128
2024164
2025196
2026120
196+20%
Topical retinoid — PubMed papers per year, 2016–2026 (2026 partial)
Topical retinoid
2016121
2017121
2018110
2019127
2020141
2021155
2022138
2023150
2024162
2025169
2026110
169+4%
Ablative / hybrid fractional laser — PubMed papers per year, 2016–2026 (2026 partial)
Ablative / hybrid fractional laser
2016100
201782
201880
2019100
2020118
2021141
2022111
202384
202494
2025134
202683
134+43%
Mechanical microneedling — PubMed papers per year, 2016–2026 (2026 partial)
Mechanical microneedling
201617
201725
201829
201947
202057
202161
202269
202374
202492
2025119
202675
119+29%
Non-ablative fractional laser — PubMed papers per year, 2016–2026 (2026 partial)
Non-ablative fractional laser
201690
201773
201882
201978
202090
202183
202293
202366
202482
2025111
202654
111+35%
Poly-L-lactic acid collagen stimulator — PubMed papers per year, 2016–2026 (2026 partial)
Poly-L-lactic acid collagen stimulator
201613
201718
201815
201915
202032
202132
202227
202335
202465
2025109
202676
109+68%
Calcium hydroxylapatite filler — PubMed papers per year, 2016–2026 (2026 partial)
Calcium hydroxylapatite filler
201620
201723
201834
201919
202035
202129
202239
202345
202464
202594
202658
94+47%
Pulsed dye laser — PubMed papers per year, 2016–2026 (2026 partial)
Pulsed dye laser
201655
201763
201867
201954
202061
202183
202268
202362
202478
202588
202646
88+13%
Topical hydroquinone / triple combination — PubMed papers per year, 2016–2026 (2026 partial)
Topical hydroquinone / triple combination
201646
201736
201829
201944
202051
202160
202269
202356
202470
202570
202658
700%
Risers · 2025 vs 2024Botulinum toxin (cosmetic)+25%Poly-L-lactic acid collagen stimulator+68%Ablative / hybrid fractional laser+43%Hyaluronic acid filler+20%Calcium hydroxylapatite filler+47%
FallersCellulite septa release−80%Hydradermabrasion−78%Laser hair removal−8%High-intensity electromagnetic muscle stimulation−38%Non-invasive laser lipolysis−25%

PubMed papers per year per treatment; deltas are 2025 vs 2024 on the stated base.

Evidence quality

23 modalities · 1,467 registered studies readmethod →See more

Four separate facts about the registered literature — who paid, how many humans, what came back, how concentrated. None of them is a score.

Independent vs industry-funded trials

10 largest registered evidence bases · ordered by industry share

Each column is one modality; each band is the lead-sponsor classSponsor classThe registry's grouping of who ran a study — a company, the national health agency, another government body, or the catch-all bucket that holds hospitals and universities. the registry recorded, and the colours here are sponsor classes, not site categories.

Axis labels are shortened names. Terms in them: Dermal fillerDermal fillerAn injected gel that adds volume under the skin. · NeuromodulatorNeuromodulatorAn injected product that temporarily relaxes a muscle, which is the category botulinum toxin products sit in. · RFRFRadiofrequency: energy that heats tissue from the inside by passing an electrical current through it rather than by shining light on it. · BBLBBLBroadband light: one manufacturer's name for its intense pulsed light platform.

Lead-sponsor class of every registered study, by modality

share of each modality's registered studies

University, hospital or other accounts for 86–92% of registered trials for Pulsed dye laser, Ablative / hybrid fractional laser and Non-ablative fractional laser, and 15–23% for Hyaluronic acid filler and Botulinum toxin (cosmetic).

0255075100100HyaluronicBotulinumRF needlingRetinoidBroadbandHydroquinoneMicroneedlingNon-ablativeAblative100Pulsed dye
Other464%

Other combines 5 series each under 3% of the total: NIH, Other US federal agency, Other government, Research network and Individual. Each keeps its own colour in the chart and its own row in the data table.

Lead-sponsor class mix per modality, in whole percentage points of that modality's registered studies (they sum to 100 by largest remainder; the study counts are in the table below)
IndustryNIHOther US federal agencyOther governmentResearch networkIndividualUniversity, hospital or otherTotal
Hyaluronic810004015100
Botulinum750011023100
RF needling540000046100
Retinoid471021148100
Broadband370032058100
Hydroquinone350042059100
Microneedling180160075100
Non-ablative120011086100
Ablative110021086100
Pulsed dye80000092100

Lead sponsor only. A trial run by a university on a manufacturer's grant is classed by its registered lead sponsor, and the registry does not publish the funding behind it.

Industry funding is not evidence of bad science — this measures who registered and paid for the trials, nothing else.

Lead-sponsor class of every fetched study, as counts rather than percentages, for each modality drawn in the figure above.
ModalityRegistered studiesIndustryNIHOther US federal agencyOther governmentResearch networkIndividualUniversity, hospital or other
Hyaluronic acid filler4637000207
Botulinum toxin (cosmetic)1861390022043
Radiofrequency microneedling37200000017
Topical retinoid34316321822165
IPL / broadband light43160011025
Topical hydroquinone / triple combination51180021030
Mechanical microneedling1352401900101
Non-ablative fractional laser1281500110111
Ablative / hybrid fractional laser2292401520197
Pulsed dye laser7260000066

Humans actually tested

median participants per trial · middle half beside it

Under each name: registered studies that reported an actual enrolment countActual enrolmentThe number of people a study finished with, recorded after it ran., out of every study registered for that modality. A third figure, where one appears, is how many of those reported an enrolment of zero. The number on the right is the medianMedianThe middle value once everything is lined up in order, which a few unusually large or small entries cannot drag around., and the range beside it is the middle half, the IQRIQRInterquartile range: the stretch covering the middle half of the values, from a quarter of the way up the list to three quarters of the way up..

  1. 1Botulinum toxin (cosmetic)165 of 186 · 3 at zero13245–300
  2. 2Calcium hydroxylapatite filler6 of 710162.5–126
  3. 3Bimatoprost for eyelash growth28 of 28 · 1 at zero79.532.2–285
  4. 4Poly-L-lactic acid collagen stimulator8 of 1779.547.5–193.2
  5. 5Hyaluronic acid filler34 of 46 · 1 at zero69.560–104.8
  1. 6Topical retinoid275 of 343 · 12 at zero6026–269
  2. 7Topical clascoterone16 of 214618–632.5
  3. 8Topical hydroquinone / triple combination34 of 513220–56
  4. 9Monopolar RF skin tightening6 of 93120.5–70
  5. 10Cryolipolysis14 of 203011.8–49

Median participants per registered trial that reported an actual enrolment; a small median means small studies, not necessarily weak ones.

Results transparency

318 of 913 completed studies across all 23 modalities

Under each name: completed registered studies with results postedResults postedWhether the people who ran a study later uploaded its actual outcome numbers to the public registry, which is a separate step from registering the study in the first place., out of that modality's completed studies. The percentage on the right is those two numbers divided.

Registration is not publication: a low rate means results were not posted to ClinicalTrials.gov, not that the device failed.

Sponsor concentration

the 5 modalities whose largest sponsor holds the most

Under each name, in order: the largest lead sponsorLead sponsorThe organisation that takes responsibility for a study, which may be a manufacturer, a hospital, a university or a government body. by name, how many of that modality's studies it registered out of the studies read, and how many distinct lead sponsors the modality has in total. The percentage on the right is the first sponsor's share — its sponsor concentrationSponsor concentrationHow much of a group of studies sits with the single busiest organisation rather than being spread across many..

  1. 1High-intensity electromagnetic muscle stimulationBTL Industries Ltd. · 4 of 4 · 1100%top 5: 100%
  2. 2Bimatoprost for eyelash growthAllergan · 20 of 28 · 871%top 5: 89%
  3. 3Calcium hydroxylapatite fillerMerz North America, Inc. · 5 of 7 · 371%top 5: 100%
  1. 4Cellulite septa releaseNorthwestern University · 2 of 4 · 350%top 5: 100%
  2. 5Monopolar RF skin tighteningCLASSYS Inc. · 3 of 9 · 733%top 5: 78%

Sponsor names are the registry's raw lead-sponsor strings — this site does not merge them, so one company spelled two ways counts twice.

Most studied

PubMed records, all time · top 10 of 25method →See every study type

Under each name, in this order: randomised controlled trialsRandomised controlled trialA study that decides by chance which participants get which treatment, so that the groups being compared start out alike and a difference at the end is easier to pin on the treatment., systematic reviewsSystematic reviewA paper that hunts down every study on one question using a search method it states up front, then summarises what the whole set shows. or meta-analysesMeta-analysisA paper that pools the numbers from several separate studies into a single combined figure., then case reportsCase reportA write-up of one patient, or a small handful, described after the fact — useful as a sign that something can happen, and no guide at all to how often it does.. The large figure on the right is every PubMed record for that treatment; the pill beside it is records carrying either of the first two types — the higher-tier countHigher-tier evidenceThis site's shorthand for the pooled papers and the randomised trials counted together in one search, so a paper carrying both labels is only counted once..

  1. 1Topical retinoid431 · 90 · 2694,253521
  2. 2Botulinum toxin (cosmetic)248 · 114 · 2002,201362
  3. 3Pulsed dye laser118 · 78 · 2871,530196
  4. 4Ablative / hybrid fractional laser233 · 74 · 1631,485307
  5. 5Hyaluronic acid filler162 · 41 · 1931,299203
  1. 6Non-ablative fractional laser188 · 46 · 1141,158234
  2. 7Topical hydroquinone / triple combination143 · 33 · 891,116176
  3. 8IPL / broadband light122 · 63 · 861,028185
  4. 9Laser hair removal56 · 29 · 12674485
  5. 10Mechanical microneedling59 · 51 · 38620110

Counting publications is not a quality measure — the study types are shown so you can see what a headline number is made of.

Device leaderboard

136 devicesmethod →See more
Sort

Under each product: the manufacturer, then the FDA route and the identifier on the record — clearedClearedThe word for a product that came through the 510(k) route, where the FDA agreed it works much like something already on sale. is the word for the 510(k) route, approved for the rest. The figure on the right is whichever measure the column head names.

ProductPapers · modality, last 10 years

Literature counts are for the MODALITY, never the brand — brands sharing a modality legitimately share the number.

  1. 1ASCE+— not crosswalked2,35379
  2. 2Botox CosmeticALLERGAN · Approved BLA1030001,362186Oct 18, 2024+25%
  3. 3DaxxifyREVANCE THERAPEUTICS, INC. · Approved BLA7611271,362186Aug 11, 2023+25%
  4. 4DysportIPSEN BIOPHARM LTD · Approved BLA1252741,362186Sep 21, 2023+25%
  5. 5JeuveauEVOLUS INC · Approved BLA7610851,362186Jul 12, 2019+25%
  6. 6LetyboHUGEL INC · Approved BLA7612251,362186Feb 29, 2024+25%
  7. 7XeominMERZ PHARMS · Approved BLA1253601,362186Jun 25, 2026+25%
  8. 8AkliefGALDERMA LABS LP · Approved NDA2115271,332343Jul 19, 2022+4%
  9. 9DifferinGALDERMA LABS LP · Approved NDA0203801,332343Dec 27, 2023+4%
  10. 10RenovaVALEANT PHARMS NORTH · Approved NDA0211081,332343May 25, 2016+4%
  11. 11Retin-ABAUSCH · Approved NDA0173401,332343May 13, 2016+4%
  12. 12TazoracALMIRALL · Approved NDA0206001,332343Apr 16, 2018+4%
  13. 13Belotero BalanceMerz North America, Inc. · Approved P0900161,03346May 3, 2026+20%
  14. 14Belotero Intense (+) LidocaineMerz North America, Inc. · Approved P2500161,03346Jul 9, 2026+20%
  15. 15Belotero Volume (+) LidocaineMerz North America, Inc. · Approved P2500201,03346Jun 25, 2026+20%
  1. 16Juvederm Ultra XCAllergan · Approved P0500471,03346Aug 14, 2025+20%
  2. 17Juvederm Volbella XCAllergan · Approved P1100331,03346Aug 14, 2025+20%
  3. 18Juvederm Vollure XCAllergan · Approved P1100331,03346Aug 14, 2025+20%
  4. 19Juvederm Voluma XCAllergan · Approved P1100331,03346May 8, 2025+20%
  5. 20Juvederm Volux XCAllergan · Approved P1100331,03346Aug 14, 2025+20%
  6. 21Profhilo— not crosswalked1,03346+20%
  7. 22RHA CollectionTeoxane S.A. · Approved P1700021,03346Jul 2, 2026+20%
  8. 23Restylane DefyneQ-Med AB · Approved P1400291,03346Apr 14, 2026+20%
  9. 24Restylane KysseQ-Med AB · Approved P1400291,03346Apr 14, 2026+20%
  10. 25Restylane LyftQ-Med AB · Approved P0400241,03346Feb 5, 2026+20%
  11. 26Restylane SilkQ-Med AB · Approved P0400241,03346Dec 23, 2022+20%
  12. 27Revanesse VersaProllenium Medical Technologies, Inc. · Approved P1600421,03346May 8, 2026+20%
  13. 28SKINVIVE by JuvedermAllergan · Approved P1100331,03346Jun 11, 2026+20%
  14. 29AcuPulseLumenis, Ltd. · Cleared K212703940229Oct 19, 2021+43%
  15. 30Alma HybridAlma Lasers, Inc. · Cleared K251230940229May 21, 2025+43%
  16. 31CO2RESyneron-Candela Corp · Cleared K181523940229Jul 11, 2018+43%
  17. 32Halo— not crosswalked940229+43%
  18. 33SP DynamisFotona D.O.O. · Cleared K213267940229Sep 8, 2022+43%
  19. 34SmartXideEl.En S.P.A. · Cleared K240537940229Mar 20, 2024+43%
  20. 35UltraPulseLumenis Be, Ltd. · Cleared K233301940229Dec 1, 2023+43%
  21. 36eCO2Lutronic Corporation · Cleared K244060940229Jul 31, 2025+43%
  22. 37Clear + BrilliantSolta Medical, Inc. · Cleared K223647742128Dec 29, 2022+35%
  23. 38FraxCandela Corporation · Cleared K212492742128Dec 20, 2021+35%
  24. 39FraxelSolta Medical · Cleared K242142742128Aug 21, 2024+35%
  25. 40LaseMDLutronic Global · Cleared K192331742128Nov 12, 2019+35%
  26. 41CynergyCynosure, Inc. · Cleared K05077961372Jun 27, 2005+13%
  27. 42VbeamCandela Corporation · Cleared K23099061372Jun 1, 2023+13%
  28. 43MicroPen EVOEclipse Medcorp, LLC · Cleared K212558564135Nov 24, 2021+29%
  29. 44Rejuvapen NXTRefine USA, LLC · Cleared K192138564135Apr 9, 2020+29%
  30. 45SkinPenCrown Aesthetics · Cleared K241400564135Aug 29, 2024+29%
  31. 46SkinStylusEsthetic Medical, Inc. · Cleared K253002564135Feb 19, 2026+29%
  32. 47ellacorCytrellis Biosystems, Inc. · Cleared K252752564135Oct 30, 2025+29%
  33. 48Tri-LumaGALDERMA LABS LP · Approved NDA02111250951Jan 20, 20150%
  34. 49BBLSciton, Inc · Cleared K03246048843Nov 13, 2003+33%
  35. 50Harmony XLAlma Lasers, Inc. · Cleared K24304448843Apr 11, 2025+33%
  36. 51IconCynosure, Inc. · Cleared K14237648843Sep 24, 2014+33%
  37. 52NordlysCandela Corporation · Cleared K21249248843Dec 20, 2021+33%
  38. 53Stellar M22Lumenis Be, Ltd. · Cleared K25080948843Apr 16, 2025+33%
  39. 54RadiesseMerz North America, Inc. · Approved P0500374087Aug 20, 2014+47%
  40. 55SculptraQ-Med AB · Approved P03005037117Jun 22, 2026+68%
  41. 56Apogee EliteCynosure, Inc. · Cleared K03403035930Feb 9, 2004−8%
  42. 57Clarity IILutronic Corporation · Cleared K18356635930Jun 14, 2019−8%
  43. 58DiolazeInmode MD , Ltd. · Cleared K18071935930Jun 14, 2018−8%
  44. 59Elite iQCynosure, LLC · Cleared K24039635930Mar 8, 2024−8%
  45. 60GentleLaseCandela Corp. · Cleared K14073235930Nov 7, 2014−8%
  46. 61GentleMax ProCandela Corporation · Cleared K20111135930May 26, 2020−8%
  47. 62LightSheerLumenis, Ltd. · Cleared K17017935930Sep 18, 2017−8%
  48. 63MotusEl.En S.P.A. · Cleared K24145935930Jun 21, 2024−8%
  49. 64SopranoAlma Lasers, Inc. · Cleared K23037135930Feb 22, 2023−8%
  50. 65Splendor XBios S.R.L. · Cleared K24344535930Dec 30, 2024−8%
  51. 66VectusPalomar Medical Technologies, Inc. · Cleared K12062235930May 23, 2012−8%
  52. 67AestheFill— not crosswalked33649
  53. 68Discovery PicoQuanta System Spa · Cleared K24098330627Jun 6, 2025+34%
  54. 69PicoCareWontech Co., Ltd. · Cleared K18127230627Jul 31, 2018+34%
  55. 70PicoPlusLutronic Corporation · Cleared K17370030627Jun 19, 2018+34%
  56. 71PicoSureCynosure, LLC · Cleared K26157030627Jun 17, 2026+34%
  57. 72PicoWayCandela Corporation · Cleared K22085330627Oct 13, 2022+34%
  58. 73enlightenCutera, Inc. · Cleared K18299730627Dec 12, 2018+34%
  59. 74Agnes RFAgnes Medical Co., Ltd. · Cleared K25021730437Sep 3, 2025+11%
  60. 75EndyMed IntensifEndymed Medical, Ltd. · Cleared K13050130437Mar 13, 2014+11%
  61. 76FractoraInvasix , Ltd. · Cleared K10246130437Jun 2, 2011+11%
  62. 77GeniusCynosure Lutronic Technology Corporation · Cleared K25348430437Jun 29, 2026+11%
  63. 78INTRAcelJeisys Medical, Inc. · Cleared K18328430437Jan 15, 2020+11%
  64. 79InfiniLutronic Corporation · Cleared K12148130437Jun 25, 2013+11%
  65. 80Morpheus8InMode , Ltd. · Cleared K24001730437Jun 13, 2024+11%
  66. 81PotenzaJeisys Medical, Inc. · Cleared K23121630437Dec 10, 2024+11%
  67. 82ProfoundCandela Corporation · Cleared K24007030437Jul 1, 2024+11%
  68. 83Scarlet SRFVIOL Co., Ltd. · Cleared K18087230437Oct 11, 2018+11%
  69. 84Secret ProIlooda Co,., Ltd. · Cleared K23337430437Dec 14, 2023+11%
  70. 85Secret RFIlooda Co,., Ltd. · Cleared K18235530437Sep 6, 2019+11%
  71. 86Sylfirm XVIOL Co., Ltd. · Cleared K21361230437Jun 23, 2022+11%
  72. 87Venus VivaVenus Concept USA, Inc. · Cleared K20116430437Jun 26, 2020+11%
  73. 88VirtueRFShenB Co., Ltd. · Cleared K21156230437Nov 23, 2021+11%
  74. 89VivaceShenB Co., Ltd. · Cleared K19307030437Apr 26, 2021+11%
  75. 90TempSureCynosure, LLC · Cleared K2232922939Nov 23, 2022+57%
  76. 91ThermageSolta Medical · Cleared K1737592939Jan 8, 2018+57%
  77. 92VolnewmerClassys, Inc. · Cleared K2402482939Apr 29, 2024+57%
  78. 93SofwaveSofwave Medical, Ltd. · Cleared K25014626116Apr 18, 2025+73%
  79. 94UltherapyUlthera, Inc. · Cleared K26061826116May 21, 2026+73%
  80. 95CoolSculptingZeltiq Aesthetics, Inc. · Cleared K19356619920Jan 21, 2020+75%
  81. 96CoolSculpting EliteZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · Cleared K23373219920Sep 12, 2024+75%
  82. 97AccentAlma Lasers, Inc. · Cleared K1011471740Jan 21, 2011+38%
  83. 98ExilisBTL Industries, Inc. · Cleared K1631761740Jan 12, 2017+38%
  84. 99NuEra TightBios S.R.L. · Cleared K2307551740Oct 30, 2023+38%
  85. 100VelaShapeSyneron Medical, Ltd. · Cleared K1225791740Sep 13, 2012+38%
  86. 101Venus LegacyVenus Concept USA, Inc. · Cleared K1915281740Sep 6, 2019+38%
  87. 102truSculptCutera, Inc. · Cleared K1807091740Jun 6, 2018+38%
  88. 103truSculpt iDCutera, Inc. · Cleared K2231101740Nov 3, 2022+38%
  89. 104Rejuran— not crosswalked12116
  90. 105CellREDM— not crosswalked112106
  91. 106Elravie Re2O— not crosswalked112106
  92. 107Juveacell— not crosswalked112106
  93. 108WinleviSUN PHARM · Approved NDA2134338821Mar 18, 2022+17%
  94. 109HydraFacial— not crosswalked739−78%
  95. 110CoolToneZimmer Medizinsysteme GmbH · Cleared K253408614Jan 16, 2026−38%
  96. 111Emsculpt NEO— not crosswalked614−38%
  97. 112LatisseABBVIE · Approved NDA0223695228Aug 26, 20210%
  98. 113Emerald LaserErchonia Corporation · Cleared K192544490Jan 13, 2020−25%
  99. 114SculpSureCynosure · Cleared K182741490Jan 3, 2019−25%
  100. 115Venus BlissVenus Concept USA, Inc. · Cleared K220592490Apr 27, 2022−25%
  101. 116ZeronaErchonia Corporation · Cleared K243811490Jan 10, 2025−25%
  102. 117AveliRevelle Aesthetics, Inc. · Cleared K232153454Aug 18, 2023−80%
  103. 118CellfinaUlthera, Inc. · Cleared K192185454Oct 9, 2019−80%
  104. 119CellulazeCynosure, Inc. · Cleared K123407454Mar 29, 2013−80%
  105. 120AccureAccure Acne, Inc. · Cleared K242035405Oct 11, 2024+14%
  106. 121AviClearCutera, Inc. · Cleared K251149405Jul 11, 2025+14%
  107. 122AerolaseAerolase Medical Lasers, LLC · Cleared K120235Sep 17, 2012
  108. 123BLU-USun Pharmaceutical Industries, Inc. · Cleared K241358Jun 13, 2024
  109. 124BellafillTiger Aesthetics Medical, LLC · Approved P020012May 12, 2026
  110. 125CellumaBiophotas, Inc. · Cleared K232977Nov 21, 2023
  111. 126Ellansé— not crosswalked
  112. 127Hollywood SpectraLutronic Corporation · Cleared K213569Feb 4, 2022
  113. 128Hylenex recombinantHALOZYME THERAP · Approved BLA021859Jan 12, 2024
  114. 129KybellaABBVIE · Approved NDA206333Oct 5, 2022
  115. 130LightStimLed Intellectual Properties, LLC · Cleared K212771Jan 26, 2022
  116. 131OmniluxGlobalmed Technologies · Cleared K210948Jun 24, 2021
  117. 132RevLiteCynosure, Inc. · Cleared K133254Mar 5, 2014
  118. 133RogaineKENVUE BRANDS · Approved NDA019501Jan 14, 2026
  119. 134TRI-BEAMJeisys Medical Incorporated · Cleared K251464Oct 3, 2025
  120. 135UltraShapeSyneron Medical, Ltd. · Cleared K170370May 15, 2017
  121. 136truSculpt flexJohari Digital Healthcare Limited · Cleared K212866Dec 3, 2022

Device leaderboard: every indexed device with its modality-level evidence counts and latest FDA decision date.
DeviceManufacturerRegulatory statusPapers (modality, last 10 years)Registered studies (modality, all time)Latest FDA decision
ASCE+not crosswalked2,35379
Botox CosmeticALLERGANApproved BLA1030001,3621862024-10-18
DaxxifyREVANCE THERAPEUTICS, INC.Approved BLA7611271,3621862023-08-11
DysportIPSEN BIOPHARM LTDApproved BLA1252741,3621862023-09-21
JeuveauEVOLUS INCApproved BLA7610851,3621862019-07-12
LetyboHUGEL INCApproved BLA7612251,3621862024-02-29
XeominMERZ PHARMSApproved BLA1253601,3621862026-06-25
AkliefGALDERMA LABS LPApproved NDA2115271,3323432022-07-19
DifferinGALDERMA LABS LPApproved NDA0203801,3323432023-12-27
RenovaVALEANT PHARMS NORTHApproved NDA0211081,3323432016-05-25
Retin-ABAUSCHApproved NDA0173401,3323432016-05-13
TazoracALMIRALLApproved NDA0206001,3323432018-04-16
Belotero BalanceMerz North America, Inc.Approved P0900161,033462026-05-03
Belotero Intense (+) LidocaineMerz North America, Inc.Approved P2500161,033462026-07-09
Belotero Volume (+) LidocaineMerz North America, Inc.Approved P2500201,033462026-06-25
Juvederm Ultra XCAllerganApproved P0500471,033462025-08-14
Juvederm Volbella XCAllerganApproved P1100331,033462025-08-14
Juvederm Vollure XCAllerganApproved P1100331,033462025-08-14
Juvederm Voluma XCAllerganApproved P1100331,033462025-05-08
Juvederm Volux XCAllerganApproved P1100331,033462025-08-14
Profhilonot crosswalked1,03346
RHA CollectionTeoxane S.A.Approved P1700021,033462026-07-02
Restylane DefyneQ-Med ABApproved P1400291,033462026-04-14
Restylane KysseQ-Med ABApproved P1400291,033462026-04-14
Restylane LyftQ-Med ABApproved P0400241,033462026-02-05
Restylane SilkQ-Med ABApproved P0400241,033462022-12-23
Revanesse VersaProllenium Medical Technologies, Inc.Approved P1600421,033462026-05-08
SKINVIVE by JuvedermAllerganApproved P1100331,033462026-06-11
AcuPulseLumenis, Ltd.Cleared K2127039402292021-10-19
Alma HybridAlma Lasers, Inc.Cleared K2512309402292025-05-21
CO2RESyneron-Candela CorpCleared K1815239402292018-07-11
Halonot crosswalked940229
SP DynamisFotona D.O.O.Cleared K2132679402292022-09-08
SmartXideEl.En S.P.A.Cleared K2405379402292024-03-20
UltraPulseLumenis Be, Ltd.Cleared K2333019402292023-12-01
eCO2Lutronic CorporationCleared K2440609402292025-07-31
Clear + BrilliantSolta Medical, Inc.Cleared K2236477421282022-12-29
FraxCandela CorporationCleared K2124927421282021-12-20
FraxelSolta MedicalCleared K2421427421282024-08-21
LaseMDLutronic GlobalCleared K1923317421282019-11-12
CynergyCynosure, Inc.Cleared K050779613722005-06-27
VbeamCandela CorporationCleared K230990613722023-06-01
MicroPen EVOEclipse Medcorp, LLCCleared K2125585641352021-11-24
Rejuvapen NXTRefine USA, LLCCleared K1921385641352020-04-09
SkinPenCrown AestheticsCleared K2414005641352024-08-29
SkinStylusEsthetic Medical, Inc.Cleared K2530025641352026-02-19
ellacorCytrellis Biosystems, Inc.Cleared K2527525641352025-10-30
Tri-LumaGALDERMA LABS LPApproved NDA021112509512015-01-20
BBLSciton, IncCleared K032460488432003-11-13
Harmony XLAlma Lasers, Inc.Cleared K243044488432025-04-11
IconCynosure, Inc.Cleared K142376488432014-09-24
NordlysCandela CorporationCleared K212492488432021-12-20
Stellar M22Lumenis Be, Ltd.Cleared K250809488432025-04-16
RadiesseMerz North America, Inc.Approved P05003740872014-08-20
SculptraQ-Med ABApproved P030050371172026-06-22
Apogee EliteCynosure, Inc.Cleared K034030359302004-02-09
Clarity IILutronic CorporationCleared K183566359302019-06-14
DiolazeInmode MD , Ltd.Cleared K180719359302018-06-14
Elite iQCynosure, LLCCleared K240396359302024-03-08
GentleLaseCandela Corp.Cleared K140732359302014-11-07
GentleMax ProCandela CorporationCleared K201111359302020-05-26
LightSheerLumenis, Ltd.Cleared K170179359302017-09-18
MotusEl.En S.P.A.Cleared K241459359302024-06-21
SopranoAlma Lasers, Inc.Cleared K230371359302023-02-22
Splendor XBios S.R.L.Cleared K243445359302024-12-30
VectusPalomar Medical Technologies, Inc.Cleared K120622359302012-05-23
AestheFillnot crosswalked33649
Discovery PicoQuanta System SpaCleared K240983306272025-06-06
PicoCareWontech Co., Ltd.Cleared K181272306272018-07-31
PicoPlusLutronic CorporationCleared K173700306272018-06-19
PicoSureCynosure, LLCCleared K261570306272026-06-17
PicoWayCandela CorporationCleared K220853306272022-10-13
enlightenCutera, Inc.Cleared K182997306272018-12-12
Agnes RFAgnes Medical Co., Ltd.Cleared K250217304372025-09-03
EndyMed IntensifEndymed Medical, Ltd.Cleared K130501304372014-03-13
FractoraInvasix , Ltd.Cleared K102461304372011-06-02
GeniusCynosure Lutronic Technology CorporationCleared K253484304372026-06-29
INTRAcelJeisys Medical, Inc.Cleared K183284304372020-01-15
InfiniLutronic CorporationCleared K121481304372013-06-25
Morpheus8InMode , Ltd.Cleared K240017304372024-06-13
PotenzaJeisys Medical, Inc.Cleared K231216304372024-12-10
ProfoundCandela CorporationCleared K240070304372024-07-01
Scarlet SRFVIOL Co., Ltd.Cleared K180872304372018-10-11
Secret ProIlooda Co,., Ltd.Cleared K233374304372023-12-14
Secret RFIlooda Co,., Ltd.Cleared K182355304372019-09-06
Sylfirm XVIOL Co., Ltd.Cleared K213612304372022-06-23
Venus VivaVenus Concept USA, Inc.Cleared K201164304372020-06-26
VirtueRFShenB Co., Ltd.Cleared K211562304372021-11-23
VivaceShenB Co., Ltd.Cleared K193070304372021-04-26
TempSureCynosure, LLCCleared K22329229392022-11-23
ThermageSolta MedicalCleared K17375929392018-01-08
VolnewmerClassys, Inc.Cleared K24024829392024-04-29
SofwaveSofwave Medical, Ltd.Cleared K250146261162025-04-18
UltherapyUlthera, Inc.Cleared K260618261162026-05-21
CoolSculptingZeltiq Aesthetics, Inc.Cleared K193566199202020-01-21
CoolSculpting EliteZeltiq Aesthetics, Inc. (Acquired by Allergan AestheticsCleared K233732199202024-09-12
AccentAlma Lasers, Inc.Cleared K10114717402011-01-21
ExilisBTL Industries, Inc.Cleared K16317617402017-01-12
NuEra TightBios S.R.L.Cleared K23075517402023-10-30
VelaShapeSyneron Medical, Ltd.Cleared K12257917402012-09-13
Venus LegacyVenus Concept USA, Inc.Cleared K19152817402019-09-06
truSculptCutera, Inc.Cleared K18070917402018-06-06
truSculpt iDCutera, Inc.Cleared K22311017402022-11-03
Rejurannot crosswalked12116
CellREDMnot crosswalked112106
Elravie Re2Onot crosswalked112106
Juveacellnot crosswalked112106
WinleviSUN PHARMApproved NDA21343388212022-03-18
HydraFacialnot crosswalked739
CoolToneZimmer Medizinsysteme GmbHCleared K2534086142026-01-16
Emsculpt NEOnot crosswalked614
LatisseABBVIEApproved NDA02236952282021-08-26
Emerald LaserErchonia CorporationCleared K1925444902020-01-13
SculpSureCynosureCleared K1827414902019-01-03
Venus BlissVenus Concept USA, Inc.Cleared K2205924902022-04-27
ZeronaErchonia CorporationCleared K2438114902025-01-10
AveliRevelle Aesthetics, Inc.Cleared K2321534542023-08-18
CellfinaUlthera, Inc.Cleared K1921854542019-10-09
CellulazeCynosure, Inc.Cleared K1234074542013-03-29
AccureAccure Acne, Inc.Cleared K2420354052024-10-11
AviClearCutera, Inc.Cleared K2511494052025-07-11
AerolaseAerolase Medical Lasers, LLCCleared K1202352012-09-17
BLU-USun Pharmaceutical Industries, Inc.Cleared K2413582024-06-13
BellafillTiger Aesthetics Medical, LLCApproved P0200122026-05-12
CellumaBiophotas, Inc.Cleared K2329772023-11-21
Ellansénot crosswalked
Hollywood SpectraLutronic CorporationCleared K2135692022-02-04
Hylenex recombinantHALOZYME THERAPApproved BLA0218592024-01-12
KybellaABBVIEApproved NDA2063332022-10-05
LightStimLed Intellectual Properties, LLCCleared K2127712022-01-26
OmniluxGlobalmed TechnologiesCleared K2109482021-06-24
RevLiteCynosure, Inc.Cleared K1332542014-03-05
RogaineKENVUE BRANDSApproved NDA0195012026-01-14
TRI-BEAMJeisys Medical IncorporatedCleared K2514642025-10-03
UltraShapeSyneron Medical, Ltd.Cleared K1703702017-05-15
truSculpt flexJohari Digital Healthcare LimitedCleared K2128662022-12-03

Clearance cadence

11 full monthsmethod →See more

Narrow (unambiguously aesthetic) codes

clearances per month

05101520Aug2025Sep16OctNovDecJan2026FebMarAprMay9Jun
510(k) clearances per full month, narrow codes, by category
Lasers & LightBody ContouringSkin & TopicalsRF & MicroneedlingTotal
Aug60028
Sep60017
Oct1300316
Nov60006
Dec1130014
Jan40015
Feb31015
Mar70029
Apr21014
May42017
Jun90009

510(k) decisions per month in unambiguously aesthetic codes — filing tempo, not adoption.

Manufacturers

72 companies in 365 daysmethod →See more

Narrow-code clearances per applicant, trailing 365 days

clearances

Shenzhen Kaiyan Medical Equipment Co., Ltd. is the largest bar at 10 clearances, 11% of the 93 shown, while the 6 smallest bars each show 2.

Shenzhen Kaiyan Medical Equipment Co., Ltd.10
Shenzhen Ulike Smart Electronics Co., Ltd.5
Guangdong Newdermo Biotech Co., Ltd.3
Erchonia Corporation2
Heat IN A Click, LLC2
Light Tree Ventures Europe B.V.2
Merchsource, LLC2
Pollogen, Ltd.2
Sunglor Technology Co., Ltd.2
Others (63 companies)every one with a single clearance63
510(k) narrow-code clearances per applicant, 2025-07-25 to 2026-07-25
Clearances
Shenzhen Kaiyan Medical Equipment Co., Ltd.10
Shenzhen Ulike Smart Electronics Co., Ltd.5
Guangdong Newdermo Biotech Co., Ltd.3
Erchonia Corporation2
Heat IN A Click, LLC2
Light Tree Ventures Europe B.V.2
Merchsource, LLC2
Pollogen, Ltd.2
Sunglor Technology Co., Ltd.2
Others (63 companies)63

Filing count tracks paperwork activity, not sales — one platform can file many 510(k)s.

Filing concentration, 2019–2026

clearances per year · all tracked codes · 2026 partial

Clearances a year rose 75% between 2019 and 2025, from 146 to 255.

010020030020192021202320252026

Values and shares are 2025, the latest full year.

510(k) clearances per year: that year's top-12 applicants vs all others
Top-12 filers (that year)All other filersTotal
201934112146
202037119156
202133133166
202233168201
202340178218
202450179229
202557198255
20263278110

Share of 510(k) filings, explicitly NOT market share — and applicant names are unnormalised FDA strings.

Clinical trial activity

29 modalitiesmethod →See more

Under each name is the category it sits in. On the right: registered studiesRegistered studyA study written into the public registry, which records that someone planned or ran it and says nothing about whether it finished or what it found. of all time on ClinicalTrials.govClinicalTrials.govThe United States public registry where the people running a study record it before or during the study, which is where this site's study counts come from., then the pill is how many of them were recruiting on the run date.

Registered studies naming the treatment — registration is not completion, publication or result.

Cleared recently

44 in 90 daysmethod →See the full feed

Each row: the FDA decision dateDecision dateThe date the FDA recorded its decision on a submission, which is the date this site counts a clearance under., the device name as the record spells it, then the applicant and category. The mono-spaced pill is the K-number, and it opens that record on openFDA. A row tagged “Broad code” came from GEX, GEI or NGX, which also carry non-aesthetic devices.

  1. Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · RF & MicroneedlingRF & MicroneedlingK253480
  2. ChromixTermosalud S.L. · Lasers & LightLasers & LightK261473
  3. THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp. · RF & MicroneedlingRF & MicroneedlingK254056Broad code
  4. LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd. · Lasers & LightLasers & LightK261052
  5. LUTRONIC GENIUSCynosure Lutronic Technology Corporation · RF & MicroneedlingRF & MicroneedlingK253484Broad code
  6. Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd. · RF & MicroneedlingRF & MicroneedlingK251492Broad code
  7. Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd. · Lasers & LightLasers & LightK261253
  8. Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd. · Lasers & LightLasers & LightK261701Broad code
  9. LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. · Lasers & LightLasers & LightK260946
  10. Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions · RF & MicroneedlingRF & MicroneedlingK260636Broad code
  11. PICOSURE WORKSTATIONCynosure, LLC · Lasers & LightLasers & LightK261570Broad code
  12. CoolSeal Generator® (CSL-200-90)Hologic, Inc. · RF & MicroneedlingRF & MicroneedlingK253634Broad code
  13. NEUROMARK System (NMK00301)Neurent Medical , Ltd. · RF & MicroneedlingRF & MicroneedlingK261833Broad code
  14. Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd. · Lasers & LightLasers & LightK260899
  15. LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & LightLasers & LightK254025
  16. Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,Ltd · Lasers & LightLasers & LightK253231
  17. Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd. · Lasers & LightLasers & LightK261204
  18. LAP-iX2NSejong Medical Co., Ltd. · RF & MicroneedlingRF & MicroneedlingK253165Broad code
  19. OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · RF & MicroneedlingRF & MicroneedlingK253656Broad code
  20. Alma TED+ SystemAlma Lasers, Inc. · Lasers & LightLasers & LightK251684
  1. LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,Ltd · Lasers & LightLasers & LightK260690Broad code
  2. CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · Lasers & LightLasers & LightK260715
  3. Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · RF & MicroneedlingRF & MicroneedlingK253918Broad code
  4. MILAN SystemLumenis Be, Ltd. · RF & MicroneedlingRF & MicroneedlingK253803Broad code
  5. ENTire IRE SystemEntire Medical , Ltd. · RF & MicroneedlingRF & MicroneedlingK261202Broad code
  6. LASEmaR 1500Eufoton S.R.L. · Lasers & LightLasers & LightK260489Broad code
  7. LUNE PureHygieneEnamel Pure · Lasers & LightLasers & LightK260138Broad code
  8. VIVA combo RF SystemStarmed Co., Ltd. · RF & MicroneedlingRF & MicroneedlingK252833Broad code
  9. Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd. · Lasers & LightLasers & LightK261325
  10. Ulthera® SystemUlthera, Inc. · Body ContouringBody ContouringK260618
  11. Boston 2910 (Boston 2910)Boston Aesthetics, Inc. · Lasers & LightLasers & LightK253245Broad code
  12. IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd. · Lasers & LightLasers & LightK260594
  13. LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)Lagis Enterprise Co., Ltd. · RF & MicroneedlingRF & MicroneedlingK253134Broad code
  14. RhinAer+ StylusAerin Medical, Inc. · RF & MicroneedlingRF & MicroneedlingK260522Broad code
  15. MOSES Raydar™Boston Scientific Corporation · Lasers & LightLasers & LightK260100Broad code
  16. Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd. · RF & MicroneedlingRF & MicroneedlingK252591
  17. myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V. · Lasers & LightLasers & LightK260415
  18. PICO SHINING (PICO-K; PICOFY)Speclipse, Inc. · Lasers & LightLasers & LightK261214Broad code
  19. CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd. · Lasers & LightLasers & LightK260974Broad code
  20. Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd. · Lasers & LightLasers & LightK260742
  21. Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Body ContouringBody ContouringK260688
  22. Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · Lasers & LightLasers & LightK260256Broad code
  23. Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Leaseir Technologies, Slu · Lasers & LightLasers & LightK253251Broad code
  24. YellowStarAsclepion Laser Technologies GmbH · Lasers & LightLasers & LightK261094Broad code

510(k) decisions in the aesthetic product codes we track — filings, not sales, safety or efficacy.

Not here: adverse-event data, and sales, usage or market share — none of it exists in a source we would publish.