Dalphene Index

Every indexed aesthetic device, sortable by four public metrics

Updated Jul 26, 2026

The whole leaderboard — every indexed product, every sort mode, filterable by category.

136Products indexed
125Crosswalked to FDA records11 not matched
29Modalities tracked
4FDA pathways represented90 510(k) · 18 PMA · 10 NDA · 7 BLA

Every indexed product

136 products · 125 crosswalkedmethod →
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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. means it came through 510(k)510(k)A submission in which a company shows the FDA that its device works much like a device already legally on sale, so the company does not have to prove the whole thing over from scratch., approved means PMAPMAPremarket approval: the FDA's most demanding device review, in which the company has to hand over its own clinical evidence that the device is safe and does what it claims., BLABLABiologics licence application: the route used for products grown or purified from living sources, such as botulinum toxins. or NDANDANew drug application: the route used for a new drug, including injectable products regulated as drugs rather than as devices.. A product this Index could not crosswalkCrosswalkThe 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 an FDA record says so instead, with the reason. The figure on the right is a modalityModalityA 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.-level count, never a brand-level one.

ProductPapers · modality, last 10 years

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

  1. 1ASCE+— not crosswalked2,353790
  2. 2Botox CosmeticALLERGAN · Approved BLA1030001,362186Oct 18, 2024Dec 9, 19911+25%
  3. 3DaxxifyREVANCE THERAPEUTICS, INC. · Approved BLA7611271,362186Aug 11, 2023Sep 7, 20221+25%
  4. 4DysportIPSEN BIOPHARM LTD · Approved BLA1252741,362186Sep 21, 2023Apr 29, 20091+25%
  5. 5JeuveauEVOLUS INC · Approved BLA7610851,362186Jul 12, 2019Feb 1, 20191+25%
  6. 6LetyboHUGEL INC · Approved BLA7612251,362186Feb 29, 2024Feb 29, 20241+25%
  7. 7XeominMERZ PHARMS · Approved BLA1253601,362186Jun 25, 2026Jul 30, 20101+25%
  8. 8AkliefGALDERMA LABS LP · Approved NDA2115271,332343Jul 19, 2022Oct 4, 20191+4%
  9. 9DifferinGALDERMA LABS LP · Approved NDA0203801,332343Dec 27, 2023May 31, 19962+4%
  10. 10RenovaVALEANT PHARMS NORTH · Approved NDA0211081,332343May 25, 2016Aug 31, 20001+4%
  11. 11Retin-ABAUSCH · Approved NDA0173401,332343May 13, 2016Jan 26, 19736+4%
  12. 12TazoracALMIRALL · Approved NDA0206001,332343Apr 16, 2018Jun 13, 19971+4%
  13. 13Belotero BalanceMerz North America, Inc. · Approved P0900161,03346May 3, 2026Nov 14, 201160+20%
  14. 14Belotero Intense (+) LidocaineMerz North America, Inc. · Approved P2500161,03346Jul 9, 2026Jul 9, 20261+20%
  15. 15Belotero Volume (+) LidocaineMerz North America, Inc. · Approved P2500201,03346Jun 25, 2026May 19, 20264+20%
  16. 16Juvederm Ultra XCAllergan · Approved P0500471,03346Aug 14, 2025Jan 7, 201019+20%
  17. 17Juvederm Volbella XCAllergan · Approved P1100331,03346Aug 14, 2025May 31, 201640+20%
  18. 18Juvederm Vollure XCAllergan · Approved P1100331,03346Aug 14, 2025Mar 17, 201732+20%
  19. 19Juvederm Voluma XCAllergan · Approved P1100331,03346May 8, 2025Oct 22, 201335+20%
  20. 20Juvederm Volux XCAllergan · Approved P1100331,03346Aug 14, 2025Jul 29, 202218+20%
  21. 21Profhilo— not crosswalked1,033460+20%
  22. 22RHA CollectionTeoxane S.A. · Approved P1700021,03346Jul 2, 2026Oct 19, 201752+20%
  23. 23Restylane DefyneQ-Med AB · Approved P1400291,03346Apr 14, 2026Dec 9, 201638+20%
  24. 24Restylane KysseQ-Med AB · Approved P1400291,03346Apr 14, 2026Mar 26, 202020+20%
  25. 25Restylane LyftQ-Med AB · Approved P0400241,03346Feb 5, 2026Aug 31, 201518+20%
  26. 26Restylane SilkQ-Med AB · Approved P0400241,03346Dec 23, 2022Jun 13, 201425+20%
  27. 27Revanesse VersaProllenium Medical Technologies, Inc. · Approved P1600421,03346May 8, 2026Oct 2, 201720+20%
  28. 28SKINVIVE by JuvedermAllergan · Approved P1100331,03346Jun 11, 2026May 11, 202318+20%
  29. 29AcuPulseLumenis, Ltd. · Cleared K212703940229Oct 19, 2021Dec 18, 20086+43%
  30. 30Alma HybridAlma Lasers, Inc. · Cleared K251230940229May 21, 2025Jul 2, 20212+43%
  31. 31CO2RESyneron-Candela Corp · Cleared K181523940229Jul 11, 2018Sep 15, 20152+43%
  32. 32Halo— not crosswalked9402290+43%
  33. 33SP DynamisFotona D.O.O. · Cleared K213267940229Sep 8, 2022Jul 1, 20114+43%
  34. 34SmartXideEl.En S.P.A. · Cleared K240537940229Mar 20, 2024May 9, 200310+43%
  35. 35UltraPulseLumenis Be, Ltd. · Cleared K233301940229Dec 1, 2023Aug 13, 199110+43%
  36. 36eCO2Lutronic Corporation · Cleared K244060940229Jul 31, 2025Jul 7, 20084+43%
  37. 37Clear + BrilliantSolta Medical, Inc. · Cleared K223647742128Dec 29, 2022May 3, 20113+35%
  38. 38FraxCandela Corporation · Cleared K212492742128Dec 20, 2021Sep 16, 20163+35%
  39. 39FraxelSolta Medical · Cleared K242142742128Aug 21, 2024Jul 5, 200512+35%
  40. 40LaseMDLutronic Global · Cleared K192331742128Nov 12, 2019Jun 23, 20172+35%
  41. 41CynergyCynosure, Inc. · Cleared K05077961372Jun 27, 2005Jan 12, 20052+13%
  42. 42VbeamCandela Corporation · Cleared K23099061372Jun 1, 2023Feb 11, 20027+13%
  43. 43MicroPen EVOEclipse Medcorp, LLC · Cleared K212558564135Nov 24, 2021May 25, 20212+29%
  44. 44Rejuvapen NXTRefine USA, LLC · Cleared K192138564135Apr 9, 2020Apr 9, 20201+29%
  45. 45SkinPenCrown Aesthetics · Cleared K241400564135Aug 29, 2024Mar 1, 20184+29%
  46. 46SkinStylusEsthetic Medical, Inc. · Cleared K253002564135Feb 19, 2026Apr 10, 20203+29%
  47. 47ellacorCytrellis Biosystems, Inc. · Cleared K252752564135Oct 30, 2025Oct 30, 20251+29%
  48. 48Tri-LumaGALDERMA LABS LP · Approved NDA02111250951Jan 20, 2015Jan 18, 200210%
  49. 49BBLSciton, Inc · Cleared K03246048843Nov 13, 2003Nov 13, 20031+33%
  50. 50Harmony XLAlma Lasers, Inc. · Cleared K24304448843Apr 11, 2025May 23, 20087+33%
  51. 51IconCynosure, Inc. · Cleared K14237648843Sep 24, 2014Jun 22, 20112+33%
  52. 52NordlysCandela Corporation · Cleared K21249248843Dec 20, 2021Jul 7, 20154+33%
  53. 53Stellar M22Lumenis Be, Ltd. · Cleared K25080948843Apr 16, 2025Jan 21, 20155+33%
  54. 54RadiesseMerz North America, Inc. · Approved P0500374087Aug 20, 2014Dec 22, 2006100+47%
  55. 55SculptraQ-Med AB · Approved P03005037117Jun 22, 2026Aug 3, 200453+68%
  56. 56Apogee EliteCynosure, Inc. · Cleared K03403035930Feb 9, 2004Jun 29, 20003−8%
  57. 57Clarity IILutronic Corporation · Cleared K18356635930Jun 14, 2019Nov 22, 20132−8%
  58. 58DiolazeInmode MD , Ltd. · Cleared K18071935930Jun 14, 2018Jan 13, 20153−8%
  59. 59Elite iQCynosure, LLC · Cleared K24039635930Mar 8, 2024Mar 9, 20202−8%
  60. 60GentleLaseCandela Corp. · Cleared K14073235930Nov 7, 2014Dec 4, 19979−8%
  61. 61GentleMax ProCandela Corporation · Cleared K20111135930May 26, 2020Oct 5, 20114−8%
  62. 62LightSheerLumenis, Ltd. · Cleared K17017935930Sep 18, 2017May 4, 19989−8%
  63. 63MotusEl.En S.P.A. · Cleared K24145935930Jun 21, 2024Jun 19, 20174−8%
  64. 64SopranoAlma Lasers, Inc. · Cleared K23037135930Feb 22, 2023Apr 14, 20098−8%
  65. 65Splendor XBios S.R.L. · Cleared K24344535930Dec 30, 2024Jun 14, 20242−8%
  66. 66VectusPalomar Medical Technologies, Inc. · Cleared K12062235930May 23, 2012May 23, 20121−8%
  67. 67AestheFill— not crosswalked336490
  68. 68Discovery PicoQuanta System Spa · Cleared K24098330627Jun 6, 2025Dec 5, 20165+34%
  69. 69PicoCareWontech Co., Ltd. · Cleared K18127230627Jul 31, 2018Jun 12, 20172+34%
  70. 70PicoPlusLutronic Corporation · Cleared K17370030627Jun 19, 2018Jun 19, 20181+34%
  71. 71PicoSureCynosure, LLC · Cleared K26157030627Jun 17, 2026Nov 27, 20128+34%
  72. 72PicoWayCandela Corporation · Cleared K22085330627Oct 13, 2022Apr 16, 20157+34%
  73. 73enlightenCutera, Inc. · Cleared K18299730627Dec 12, 2018Oct 28, 20164+34%
  74. 74Agnes RFAgnes Medical Co., Ltd. · Cleared K25021730437Sep 3, 2025Jan 5, 20175+11%
  75. 75EndyMed IntensifEndymed Medical, Ltd. · Cleared K13050130437Mar 13, 2014Mar 13, 20141+11%
  76. 76FractoraInvasix , Ltd. · Cleared K10246130437Jun 2, 2011Jun 2, 20111+11%
  77. 77GeniusCynosure Lutronic Technology Corporation · Cleared K25348430437Jun 29, 2026Dec 10, 20182+11%
  78. 78INTRAcelJeisys Medical, Inc. · Cleared K18328430437Jan 15, 2020Jul 21, 20162+11%
  79. 79InfiniLutronic Corporation · Cleared K12148130437Jun 25, 2013Jun 25, 20131+11%
  80. 80Morpheus8InMode , Ltd. · Cleared K24001730437Jun 13, 2024Dec 27, 20193+11%
  81. 81PotenzaJeisys Medical, Inc. · Cleared K23121630437Dec 10, 2024Feb 20, 20204+11%
  82. 82ProfoundCandela Corporation · Cleared K24007030437Jul 1, 2024Sep 12, 20163+11%
  83. 83Scarlet SRFVIOL Co., Ltd. · Cleared K18087230437Oct 11, 2018Oct 11, 20181+11%
  84. 84Secret ProIlooda Co,., Ltd. · Cleared K23337430437Dec 14, 2023Dec 14, 20231+11%
  85. 85Secret RFIlooda Co,., Ltd. · Cleared K18235530437Sep 6, 2019Jun 13, 20172+11%
  86. 86Sylfirm XVIOL Co., Ltd. · Cleared K21361230437Jun 23, 2022Apr 22, 20202+11%
  87. 87Venus VivaVenus Concept USA, Inc. · Cleared K20116430437Jun 26, 2020May 12, 20153+11%
  88. 88VirtueRFShenB Co., Ltd. · Cleared K21156230437Nov 23, 2021Jan 22, 20212+11%
  89. 89VivaceShenB Co., Ltd. · Cleared K19307030437Apr 26, 2021Jan 15, 20162+11%
  90. 90TempSureCynosure, LLC · Cleared K2232922939Nov 23, 2022Sep 22, 20176+57%
  91. 91ThermageSolta Medical · Cleared K1737592939Jan 8, 2018Jul 19, 200016+57%
  92. 92VolnewmerClassys, Inc. · Cleared K2402482939Apr 29, 2024Apr 29, 20241+57%
  93. 93SofwaveSofwave Medical, Ltd. · Cleared K25014626116Apr 18, 2025Nov 15, 202110+73%
  94. 94UltherapyUlthera, Inc. · Cleared K26061826116May 21, 2026Sep 11, 200910+73%
  95. 95CoolSculptingZeltiq Aesthetics, Inc. · Cleared K19356619920Jan 21, 2020May 2, 201211+75%
  96. 96CoolSculpting EliteZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics · Cleared K23373219920Sep 12, 2024Nov 5, 20212+75%
  97. 97AccentAlma Lasers, Inc. · Cleared K1011471740Jan 21, 2011Apr 23, 20074+38%
  98. 98ExilisBTL Industries, Inc. · Cleared K1631761740Jan 12, 2017Nov 25, 20093+38%
  99. 99NuEra TightBios S.R.L. · Cleared K2307551740Oct 30, 2023Aug 11, 20206+38%
  100. 100VelaShapeSyneron Medical, Ltd. · Cleared K1225791740Sep 13, 2012Aug 22, 20072+38%
  101. 101Venus LegacyVenus Concept USA, Inc. · Cleared K1915281740Sep 6, 2019Aug 4, 20152+38%
  102. 102truSculptCutera, Inc. · Cleared K1807091740Jun 6, 2018Nov 2, 20125+38%
  103. 103truSculpt iDCutera, Inc. · Cleared K2231101740Nov 3, 2022Jul 13, 20222+38%
  104. 104Rejuran— not crosswalked121160
  105. 105CellREDM— not crosswalked1121060
  106. 106Elravie Re2O— not crosswalked1121060
  107. 107Juveacell— not crosswalked1121060
  108. 108WinleviSUN PHARM · Approved NDA2134338821Mar 18, 2022Aug 26, 20201+17%
  109. 109HydraFacial— not crosswalked7390−78%
  110. 110CoolToneZimmer Medizinsysteme GmbH · Cleared K253408614Jan 16, 2026Nov 15, 20194−38%
  111. 111Emsculpt NEO— not crosswalked6140−38%
  112. 112LatisseABBVIE · Approved NDA0223695228Aug 26, 2021Dec 24, 200810%
  113. 113Emerald LaserErchonia Corporation · Cleared K192544490Jan 13, 2020Jan 13, 20201−25%
  114. 114SculpSureCynosure · Cleared K182741490Jan 3, 2019May 15, 20156−25%
  115. 115Venus BlissVenus Concept USA, Inc. · Cleared K220592490Apr 27, 2022Jun 25, 20193−25%
  116. 116ZeronaErchonia Corporation · Cleared K243811490Jan 10, 2025May 14, 201211−25%
  117. 117AveliRevelle Aesthetics, Inc. · Cleared K232153454Aug 18, 2023Aug 5, 20222−80%
  118. 118CellfinaUlthera, Inc. · Cleared K192185454Oct 9, 2019Jul 29, 20154−80%
  119. 119CellulazeCynosure, Inc. · Cleared K123407454Mar 29, 2013Jan 26, 20122−80%
  120. 120AccureAccure Acne, Inc. · Cleared K242035405Oct 11, 2024Nov 17, 20222+14%
  121. 121AviClearCutera, Inc. · Cleared K251149405Jul 11, 2025Mar 24, 20223+14%
  122. 122AerolaseAerolase Medical Lasers, LLC · Cleared K120235Sep 17, 2012Sep 17, 20121
  123. 123BLU-USun Pharmaceutical Industries, Inc. · Cleared K241358Jun 13, 2024Sep 9, 20032
  124. 124BellafillTiger Aesthetics Medical, LLC · Approved P020012May 12, 2026Oct 27, 200638
  125. 125CellumaBiophotas, Inc. · Cleared K232977Nov 21, 2023Jan 15, 20143
  126. 126Ellansé— not crosswalked0
  127. 127Hollywood SpectraLutronic Corporation · Cleared K213569Feb 4, 2022Dec 28, 20076
  128. 128Hylenex recombinantHALOZYME THERAP · Approved BLA021859Jan 12, 2024Dec 2, 20051
  129. 129KybellaABBVIE · Approved NDA206333Oct 5, 2022Apr 29, 20151
  130. 130LightStimLed Intellectual Properties, LLC · Cleared K212771Jan 26, 2022Jul 1, 20108
  131. 131OmniluxGlobalmed Technologies · Cleared K210948Jun 24, 2021Jun 18, 20038
  132. 132RevLiteCynosure, Inc. · Cleared K133254Mar 5, 2014Dec 1, 20065
  133. 133RogaineKENVUE BRANDS · Approved NDA019501Jan 14, 2026Aug 17, 19883
  134. 134TRI-BEAMJeisys Medical Incorporated · Cleared K251464Oct 3, 2025Oct 3, 20251
  135. 135UltraShapeSyneron Medical, Ltd. · Cleared K170370May 15, 2017Oct 6, 20145
  136. 136truSculpt flexJohari Digital Healthcare Limited · Cleared K212866Dec 3, 2022Dec 3, 20221
Every product in the Dalphene Index with its modality-level evidence counts and its first and latest FDA decision dates.
DeviceManufacturerCategoryModalityRegulatory statusPapers (modality, last 10 years)Registered studies (modality, all time)First FDA decisionLatest FDA decision
ASCE+Injectablesexosome-preparationnot crosswalked2,35379
Botox CosmeticALLERGANInjectablesbotulinum-toxin-cosmeticApproved BLA1030001,3621861991-12-092024-10-18
DaxxifyREVANCE THERAPEUTICS, INC.Injectablesbotulinum-toxin-cosmeticApproved BLA7611271,3621862022-09-072023-08-11
DysportIPSEN BIOPHARM LTDInjectablesbotulinum-toxin-cosmeticApproved BLA1252741,3621862009-04-292023-09-21
JeuveauEVOLUS INCInjectablesbotulinum-toxin-cosmeticApproved BLA7610851,3621862019-02-012019-07-12
LetyboHUGEL INCInjectablesbotulinum-toxin-cosmeticApproved BLA7612251,3621862024-02-292024-02-29
XeominMERZ PHARMSInjectablesbotulinum-toxin-cosmeticApproved BLA1253601,3621862010-07-302026-06-25
AkliefGALDERMA LABS LPSkin & Topicalstopical-retinoidApproved NDA2115271,3323432019-10-042022-07-19
DifferinGALDERMA LABS LPSkin & Topicalstopical-retinoidApproved NDA0203801,3323431996-05-312023-12-27
RenovaVALEANT PHARMS NORTHSkin & Topicalstopical-retinoidApproved NDA0211081,3323432000-08-312016-05-25
Retin-ABAUSCHSkin & Topicalstopical-retinoidApproved NDA0173401,3323431973-01-262016-05-13
TazoracALMIRALLSkin & Topicalstopical-retinoidApproved NDA0206001,3323431997-06-132018-04-16
Belotero BalanceMerz North America, Inc.Injectableshyaluronic-acid-fillerApproved P0900161,033462011-11-142026-05-03
Belotero Intense (+) LidocaineMerz North America, Inc.Injectableshyaluronic-acid-fillerApproved P2500161,033462026-07-092026-07-09
Belotero Volume (+) LidocaineMerz North America, Inc.Injectableshyaluronic-acid-fillerApproved P2500201,033462026-05-192026-06-25
Juvederm Ultra XCAllerganInjectableshyaluronic-acid-fillerApproved P0500471,033462010-01-072025-08-14
Juvederm Volbella XCAllerganInjectableshyaluronic-acid-fillerApproved P1100331,033462016-05-312025-08-14
Juvederm Vollure XCAllerganInjectableshyaluronic-acid-fillerApproved P1100331,033462017-03-172025-08-14
Juvederm Voluma XCAllerganInjectableshyaluronic-acid-fillerApproved P1100331,033462013-10-222025-05-08
Juvederm Volux XCAllerganInjectableshyaluronic-acid-fillerApproved P1100331,033462022-07-292025-08-14
ProfhiloInjectableshyaluronic-acid-fillernot crosswalked1,03346
RHA CollectionTeoxane S.A.Injectableshyaluronic-acid-fillerApproved P1700021,033462017-10-192026-07-02
Restylane DefyneQ-Med ABInjectableshyaluronic-acid-fillerApproved P1400291,033462016-12-092026-04-14
Restylane KysseQ-Med ABInjectableshyaluronic-acid-fillerApproved P1400291,033462020-03-262026-04-14
Restylane LyftQ-Med ABInjectableshyaluronic-acid-fillerApproved P0400241,033462015-08-312026-02-05
Restylane SilkQ-Med ABInjectableshyaluronic-acid-fillerApproved P0400241,033462014-06-132022-12-23
Revanesse VersaProllenium Medical Technologies, Inc.Injectableshyaluronic-acid-fillerApproved P1600421,033462017-10-022026-05-08
SKINVIVE by JuvedermAllerganInjectableshyaluronic-acid-fillerApproved P1100331,033462023-05-112026-06-11
AcuPulseLumenis, Ltd.Lasers & Lightfractional-ablative-laserCleared K2127039402292008-12-182021-10-19
Alma HybridAlma Lasers, Inc.Lasers & Lightfractional-ablative-laserCleared K2512309402292021-07-022025-05-21
CO2RESyneron-Candela CorpLasers & Lightfractional-ablative-laserCleared K1815239402292015-09-152018-07-11
HaloLasers & Lightfractional-ablative-lasernot crosswalked940229
SP DynamisFotona D.O.O.Lasers & Lightfractional-ablative-laserCleared K2132679402292011-07-012022-09-08
SmartXideEl.En S.P.A.Lasers & Lightfractional-ablative-laserCleared K2405379402292003-05-092024-03-20
UltraPulseLumenis Be, Ltd.Lasers & Lightfractional-ablative-laserCleared K2333019402291991-08-132023-12-01
eCO2Lutronic CorporationLasers & Lightfractional-ablative-laserCleared K2440609402292008-07-072025-07-31
Clear + BrilliantSolta Medical, Inc.Lasers & Lightfractional-nonablative-laserCleared K2236477421282011-05-032022-12-29
FraxCandela CorporationLasers & Lightfractional-nonablative-laserCleared K2124927421282016-09-162021-12-20
FraxelSolta MedicalLasers & Lightfractional-nonablative-laserCleared K2421427421282005-07-052024-08-21
LaseMDLutronic GlobalLasers & Lightfractional-nonablative-laserCleared K1923317421282017-06-232019-11-12
CynergyCynosure, Inc.Lasers & Lightpulsed-dye-laserCleared K050779613722005-01-122005-06-27
VbeamCandela CorporationLasers & Lightpulsed-dye-laserCleared K230990613722002-02-112023-06-01
MicroPen EVOEclipse Medcorp, LLCRF & Microneedlingmechanical-microneedlingCleared K2125585641352021-05-252021-11-24
Rejuvapen NXTRefine USA, LLCRF & Microneedlingmechanical-microneedlingCleared K1921385641352020-04-092020-04-09
SkinPenCrown AestheticsRF & Microneedlingmechanical-microneedlingCleared K2414005641352018-03-012024-08-29
SkinStylusEsthetic Medical, Inc.RF & Microneedlingmechanical-microneedlingCleared K2530025641352020-04-102026-02-19
ellacorCytrellis Biosystems, Inc.RF & Microneedlingmechanical-microneedlingCleared K2527525641352025-10-302025-10-30
Tri-LumaGALDERMA LABS LPSkin & Topicalstopical-hydroquinone-combinationApproved NDA021112509512002-01-182015-01-20
BBLSciton, IncLasers & Lightbroadband-light-iplCleared K032460488432003-11-132003-11-13
Harmony XLAlma Lasers, Inc.Lasers & Lightbroadband-light-iplCleared K243044488432008-05-232025-04-11
IconCynosure, Inc.Lasers & Lightbroadband-light-iplCleared K142376488432011-06-222014-09-24
NordlysCandela CorporationLasers & Lightbroadband-light-iplCleared K212492488432015-07-072021-12-20
Stellar M22Lumenis Be, Ltd.Lasers & Lightbroadband-light-iplCleared K250809488432015-01-212025-04-16
RadiesseMerz North America, Inc.Injectablescalcium-hydroxylapatite-fillerApproved P05003740872006-12-222014-08-20
SculptraQ-Med ABInjectablespoly-l-lactic-acid-fillerApproved P030050371172004-08-032026-06-22
Apogee EliteCynosure, Inc.Lasers & Lightlaser-hair-removalCleared K034030359302000-06-292004-02-09
Clarity IILutronic CorporationLasers & Lightlaser-hair-removalCleared K183566359302013-11-222019-06-14
DiolazeInmode MD , Ltd.Lasers & Lightlaser-hair-removalCleared K180719359302015-01-132018-06-14
Elite iQCynosure, LLCLasers & Lightlaser-hair-removalCleared K240396359302020-03-092024-03-08
GentleLaseCandela Corp.Lasers & Lightlaser-hair-removalCleared K140732359301997-12-042014-11-07
GentleMax ProCandela CorporationLasers & Lightlaser-hair-removalCleared K201111359302011-10-052020-05-26
LightSheerLumenis, Ltd.Lasers & Lightlaser-hair-removalCleared K170179359301998-05-042017-09-18
MotusEl.En S.P.A.Lasers & Lightlaser-hair-removalCleared K241459359302017-06-192024-06-21
SopranoAlma Lasers, Inc.Lasers & Lightlaser-hair-removalCleared K230371359302009-04-142023-02-22
Splendor XBios S.R.L.Lasers & Lightlaser-hair-removalCleared K243445359302024-06-142024-12-30
VectusPalomar Medical Technologies, Inc.Lasers & Lightlaser-hair-removalCleared K120622359302012-05-232012-05-23
AestheFillInjectablespdlla-biostimulatornot crosswalked33649
Discovery PicoQuanta System SpaLasers & Lightpicosecond-laserCleared K240983306272016-12-052025-06-06
PicoCareWontech Co., Ltd.Lasers & Lightpicosecond-laserCleared K181272306272017-06-122018-07-31
PicoPlusLutronic CorporationLasers & Lightpicosecond-laserCleared K173700306272018-06-192018-06-19
PicoSureCynosure, LLCLasers & Lightpicosecond-laserCleared K261570306272012-11-272026-06-17
PicoWayCandela CorporationLasers & Lightpicosecond-laserCleared K220853306272015-04-162022-10-13
enlightenCutera, Inc.Lasers & Lightpicosecond-laserCleared K182997306272016-10-282018-12-12
Agnes RFAgnes Medical Co., Ltd.RF & Microneedlingrf-microneedlingCleared K250217304372017-01-052025-09-03
EndyMed IntensifEndymed Medical, Ltd.RF & Microneedlingrf-microneedlingCleared K130501304372014-03-132014-03-13
FractoraInvasix , Ltd.RF & Microneedlingrf-microneedlingCleared K102461304372011-06-022011-06-02
GeniusCynosure Lutronic Technology CorporationRF & Microneedlingrf-microneedlingCleared K253484304372018-12-102026-06-29
INTRAcelJeisys Medical, Inc.RF & Microneedlingrf-microneedlingCleared K183284304372016-07-212020-01-15
InfiniLutronic CorporationRF & Microneedlingrf-microneedlingCleared K121481304372013-06-252013-06-25
Morpheus8InMode , Ltd.RF & Microneedlingrf-microneedlingCleared K240017304372019-12-272024-06-13
PotenzaJeisys Medical, Inc.RF & Microneedlingrf-microneedlingCleared K231216304372020-02-202024-12-10
ProfoundCandela CorporationRF & Microneedlingrf-microneedlingCleared K240070304372016-09-122024-07-01
Scarlet SRFVIOL Co., Ltd.RF & Microneedlingrf-microneedlingCleared K180872304372018-10-112018-10-11
Secret ProIlooda Co,., Ltd.RF & Microneedlingrf-microneedlingCleared K233374304372023-12-142023-12-14
Secret RFIlooda Co,., Ltd.RF & Microneedlingrf-microneedlingCleared K182355304372017-06-132019-09-06
Sylfirm XVIOL Co., Ltd.RF & Microneedlingrf-microneedlingCleared K213612304372020-04-222022-06-23
Venus VivaVenus Concept USA, Inc.RF & Microneedlingrf-microneedlingCleared K201164304372015-05-122020-06-26
VirtueRFShenB Co., Ltd.RF & Microneedlingrf-microneedlingCleared K211562304372021-01-222021-11-23
VivaceShenB Co., Ltd.RF & Microneedlingrf-microneedlingCleared K193070304372016-01-152021-04-26
TempSureCynosure, LLCRF & Microneedlingmonopolar-rf-skin-tighteningCleared K22329229392017-09-222022-11-23
ThermageSolta MedicalRF & Microneedlingmonopolar-rf-skin-tighteningCleared K17375929392000-07-192018-01-08
VolnewmerClassys, Inc.RF & Microneedlingmonopolar-rf-skin-tighteningCleared K24024829392024-04-292024-04-29
SofwaveSofwave Medical, Ltd.Body Contouringultrasound-skin-tighteningCleared K250146261162021-11-152025-04-18
UltherapyUlthera, Inc.Body Contouringultrasound-skin-tighteningCleared K260618261162009-09-112026-05-21
CoolSculptingZeltiq Aesthetics, Inc.Body ContouringcryolipolysisCleared K193566199202012-05-022020-01-21
CoolSculpting EliteZeltiq Aesthetics, Inc. (Acquired by Allergan AestheticsBody ContouringcryolipolysisCleared K233732199202021-11-052024-09-12
AccentAlma Lasers, Inc.Body Contouringrf-body-contouringCleared K10114717402007-04-232011-01-21
ExilisBTL Industries, Inc.Body Contouringrf-body-contouringCleared K16317617402009-11-252017-01-12
NuEra TightBios S.R.L.Body Contouringrf-body-contouringCleared K23075517402020-08-112023-10-30
VelaShapeSyneron Medical, Ltd.Body Contouringrf-body-contouringCleared K12257917402007-08-222012-09-13
Venus LegacyVenus Concept USA, Inc.Body Contouringrf-body-contouringCleared K19152817402015-08-042019-09-06
truSculptCutera, Inc.Body Contouringrf-body-contouringCleared K18070917402012-11-022018-06-06
truSculpt iDCutera, Inc.Body Contouringrf-body-contouringCleared K22311017402022-07-132022-11-03
RejuranInjectablespolynucleotide-skin-boosternot crosswalked12116
CellREDMInjectableshadm-ecm-boosternot crosswalked112106
Elravie Re2OInjectableshadm-ecm-boosternot crosswalked112106
JuveacellInjectableshadm-ecm-boosternot crosswalked112106
WinleviSUN PHARMSkin & Topicalstopical-clascoteroneApproved NDA21343388212020-08-262022-03-18
HydraFacialSkin & Topicalshydradermabrasionnot crosswalked739
CoolToneZimmer Medizinsysteme GmbHBody Contouringhifem-muscle-stimulationCleared K2534086142019-11-152026-01-16
Emsculpt NEOBody Contouringhifem-muscle-stimulationnot crosswalked614
LatisseABBVIESkin & Topicalsbimatoprost-eyelashApproved NDA02236952282008-12-242021-08-26
Emerald LaserErchonia CorporationBody Contouringlaser-lipolysis-noninvasiveCleared K1925444902020-01-132020-01-13
SculpSureCynosureBody Contouringlaser-lipolysis-noninvasiveCleared K1827414902015-05-152019-01-03
Venus BlissVenus Concept USA, Inc.Body Contouringlaser-lipolysis-noninvasiveCleared K2205924902019-06-252022-04-27
ZeronaErchonia CorporationBody Contouringlaser-lipolysis-noninvasiveCleared K2438114902012-05-142025-01-10
AveliRevelle Aesthetics, Inc.Body Contouringcellulite-tissue-releaseCleared K2321534542022-08-052023-08-18
CellfinaUlthera, Inc.Body Contouringcellulite-tissue-releaseCleared K1921854542015-07-292019-10-09
CellulazeCynosure, Inc.Body Contouringcellulite-tissue-releaseCleared K1234074542012-01-262013-03-29
AccureAccure Acne, Inc.Lasers & Lightlaser-acne-sebaceousCleared K2420354052022-11-172024-10-11
AviClearCutera, Inc.Lasers & Lightlaser-acne-sebaceousCleared K2511494052022-03-242025-07-11
AerolaseAerolase Medical Lasers, LLCLasers & LightCleared K1202352012-09-172012-09-17
BLU-USun Pharmaceutical Industries, Inc.Lasers & LightCleared K2413582003-09-092024-06-13
BellafillTiger Aesthetics Medical, LLCInjectablesApproved P0200122006-10-272026-05-12
CellumaBiophotas, Inc.Lasers & LightCleared K2329772014-01-152023-11-21
EllanséInjectablesnot crosswalked
Hollywood SpectraLutronic CorporationLasers & LightCleared K2135692007-12-282022-02-04
Hylenex recombinantHALOZYME THERAPInjectablesApproved BLA0218592005-12-022024-01-12
KybellaABBVIEInjectablesApproved NDA2063332015-04-292022-10-05
LightStimLed Intellectual Properties, LLCLasers & LightCleared K2127712010-07-012022-01-26
OmniluxGlobalmed TechnologiesLasers & LightCleared K2109482003-06-182021-06-24
RevLiteCynosure, Inc.Lasers & LightCleared K1332542006-12-012014-03-05
RogaineKENVUE BRANDSSkin & TopicalsApproved NDA0195011988-08-172026-01-14
TRI-BEAMJeisys Medical IncorporatedLasers & LightCleared K2514642025-10-032025-10-03
UltraShapeSyneron Medical, Ltd.Body ContouringCleared K1703702014-10-062017-05-15
truSculpt flexJohari Digital Healthcare LimitedBody ContouringCleared K2128662022-12-032022-12-03