Dalphene Index

Every company that cleared an aesthetic device in the window

Updated Jul 26, 2026

Every applicant in the window, not the top twelve — with the single-clearance tail shown, not folded away.

Manufacturers

72 companies in 365 daysmethod →

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.

Every applicant in the window

171 companies · 132 with one clearancemethod →

Every company granted a 510(k) clearance in the tracked aesthetic product codes between 2025-07-25 and 2026-07-25, with its narrow-code and broad-code counts.

Applicant, as FDA records itApplicantThe company named on an FDA submission, which can be the maker, its parent company or the distributor that sells the device.CountryCategoriesNarrow codesNarrow codesThe FDA device codes on this site that describe unmistakably aesthetic equipment, so counts built from them leave out general-purpose surgical kit.Broad codesBroad codesFDA device codes that cover mixed uses, where aesthetic equipment shares a code with general medical equipment.TotalFirst in windowDecision dateThe date the FDA recorded its decision on a submission, which is the date this site counts a clearance under.Latest in window
Shenzhen Kaiyan Medical Equipment Co., Ltd.CN10010Aug 14, 2025Jun 16, 2026
Shenzhen Ulike Smart Electronics Co., Ltd.CN505Oct 1, 2025May 21, 2026
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.CN055Nov 20, 2025Mar 6, 2026
Boston Aesthetics, Inc.US044Jan 12, 2026May 21, 2026
Guangdong Newdermo Biotech Co., Ltd.CN303Mar 23, 2026Jun 29, 2026
Pollogen, Ltd.IL213Sep 10, 2025Oct 12, 2025
Nanjing Bestview Laser S&T Co., Ltd.CN033Sep 26, 2025May 7, 2026
Sanhe Meditech Co., Ltd.CN033Oct 31, 2025Mar 31, 2026
Speclipse, Inc.KR033Nov 25, 2025May 11, 2026
Erchonia CorporationUS202Sep 12, 2025Dec 15, 2025
Heat IN A Click, LLCUS202Aug 15, 2025Dec 24, 2025
Light Tree Ventures Europe B.V.NL202Dec 24, 2025May 12, 2026
Merchsource, LLCUS202Oct 1, 2025Oct 16, 2025
Sunglor Technology Co., Ltd.CN202Nov 19, 2025Dec 19, 2025
Alma Lasers, Inc.US112Sep 24, 2025Jun 5, 2026
El.En S.P.A.IT112Aug 6, 2025Apr 2, 2026
Lutronic CorporationKR112Jul 31, 2025Aug 11, 2025
Shenzhen Leaflife Technology Co., Ltd.CN112Aug 14, 2025Nov 25, 2025
Termosalud S.L.ES112Mar 12, 2026Jul 1, 2026
Agnes Medical Co., Ltd.KR022Aug 19, 2025Sep 3, 2025
ArthroCare CorporationUS022Mar 25, 2026Mar 30, 2026
Asclepion Laser Technologies GmbHDE022Oct 23, 2025Apr 29, 2026
Baoding Te'Anzhou Electronic Technology Co., Ltd.CN022Nov 7, 2025Nov 28, 2025
Beijing HuaCheng Taike Technology Co., Ltd.CN022Feb 27, 2026Feb 27, 2026
Boston Scientific CorporationUS022Oct 30, 2025May 18, 2026
BTL Industries, Inc.US022Feb 18, 2026Mar 17, 2026
Entire Medical , Ltd.IL022Jan 14, 2026May 29, 2026
Erbe Elektromedizin GmbHDE022Aug 29, 2025Dec 18, 2025
F Care Systems USA, LLCUS022Nov 24, 2025Jun 2, 2026
Hebei Keylaser Sci-Tech Co.,LtdCN022Nov 6, 2025Nov 7, 2025
Hebei Newangie Technology Co., Ltd.CN022Aug 8, 2025Oct 1, 2025
Hironic Co., Ltd.KR022Sep 29, 2025Apr 6, 2026
Inbella Medical, Inc.CA022Oct 15, 2025Jan 27, 2026
Micro-Energy Medical Technology Co., Ltd.CN022Dec 12, 2025Jun 18, 2026
New Deantronics Taiwan , Ltd.TW022Oct 1, 2025Jun 29, 2026
Sanhe Lefis Electronics Co., Ltd.CN022Oct 20, 2025Dec 19, 2025
Shanghai Apolo Medical Technology Co., Ltd.CN022Apr 9, 2026May 4, 2026
Starmed Co., Ltd.KR022Nov 17, 2025May 26, 2026
Zhengzhou PZ Laser Slim Technology Co., Ltd.CN022Jul 25, 2025Oct 23, 2025
Alovea Healthcare Co. , Ltd.CN101Nov 14, 2025Nov 14, 2025
Atop Lighting Co., Ltd.CN101Nov 13, 2025Nov 13, 2025
Aura Wellness, LLCUS101Dec 2, 2025Dec 2, 2025
AVAVA, Inc.US101Oct 20, 2025Oct 20, 2025
Capenergy Medical S.L.ES101Jul 10, 2026Jul 10, 2026
Contour Research, LLCUS101Feb 13, 2026Feb 13, 2026
Cosmo Far East Technology LimitedCN101Oct 22, 2025Oct 22, 2025
Cytrellis Biosystems, Inc.US101Oct 30, 2025Oct 30, 2025
Dermalogica, LLCUS101Aug 25, 2025Aug 25, 2025
Dongguan Lide Electric Appliance Co., Ltd.CN101Nov 25, 2025Nov 25, 2025
Dongguan Yanxi Technology Co., Ltd.CN101Sep 12, 2025Sep 12, 2025
Dongguan Yijiaming Technology Co., Ltd.CN101Dec 23, 2025Dec 23, 2025
El Global Trade, Ltd.IL101Jan 6, 2026Jan 6, 2026
Esthetic Medical, Inc.US101Feb 19, 2026Feb 19, 2026
Foreo, Inc.US101Feb 20, 2026Feb 20, 2026
Foshan Jindi Electric Appliance Co., Ltd.CN101Oct 10, 2025Oct 10, 2025
Gu'An Yeolight Smart Electronics Co., Ltd.CN101Nov 19, 2025Nov 19, 2025
Guangdong Ace-Tec Co., Ltd.CN101Dec 8, 2025Dec 8, 2025
Hubei Yjt Technology Co.,LtdCN101Jun 16, 2026Jun 16, 2026
Medicell Healthcare Co.,LTDKR101Mar 9, 2026Mar 9, 2026
Medicreations, LLCUS101Sep 3, 2025Sep 3, 2025
Micowey Medical Equipment (Guangxi) Co., Ltd.CN101Sep 4, 2025Sep 4, 2025
Miley Technology (Hebei) Co., Ltd.CN101Sep 15, 2025Sep 15, 2025
NOOANCEFR101Apr 22, 2026Apr 22, 2026
Philips Consumer Lifestyle B.V.NL101Dec 23, 2025Dec 23, 2025
S&M Medical Co., Ltd.KR101Mar 9, 2026Mar 9, 2026
Sanhe LEFIS Electronics Co., Ltd.CN101Jun 12, 2026Jun 12, 2026
Shenzhen Chuangtong Yigou Technology Co., Ltd.CN101Mar 11, 2026Mar 11, 2026
Shenzhen Dachi Communication Co., Ltd.CN101Nov 19, 2025Nov 19, 2025
Shenzhen Desida Technology Co., Ltd.CN101Mar 16, 2026Mar 16, 2026
Shenzhen Enmind Technology Co., Ltd.CN101Oct 2, 2025Oct 2, 2025
Shenzhen Fansizhe Science and Technology Co., Ltd.CN101Dec 29, 2025Dec 29, 2025
Shenzhen Fittop Health Technology Co., Ltd.CN101Aug 21, 2025Aug 21, 2025
Shenzhen Goodwind Technology Development Co., Ltd.CN101Dec 17, 2025Dec 17, 2025
Shenzhen Hanhua Opto Co., Ltd.CN101Mar 3, 2026Mar 3, 2026
Shenzhen Huachuangtong Industrial Co., Ltd.CN101Aug 1, 2025Aug 1, 2025
Shenzhen Jianchao Intelligent Technology Co., Ltd.CN101Jan 30, 2026Jan 30, 2026
Shenzhen Liyoutong Technology Co., Ltd.CN101Aug 7, 2025Aug 7, 2025
Shenzhen Mlay Intelligent Technology Co., Ltd.CN101Feb 23, 2026Feb 23, 2026
Shenzhen Qiaochengli Technology Co., Ltd.CN101Oct 14, 2025Oct 14, 2025
Shenzhen Rainbow Technology Co., Ltd.CN101Jan 23, 2026Jan 23, 2026
Shenzhen Saidi Light Therapy Technology Co., Ltd.CN101Dec 24, 2025Dec 24, 2025
Shenzhen Semlamp Intelligent Technology Co., Ltd.CN101Apr 21, 2026Apr 21, 2026
Shenzhen Siken 3D Technology Development Co., Ltd.CN101Dec 5, 2025Dec 5, 2025
Shenzhen Suyzeko Limited.CN101Dec 1, 2025Dec 1, 2025
Shenzhen Xiazhifeng Electronic Co., Ltd.CN101May 20, 2026May 20, 2026
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.CN101Dec 19, 2025Dec 19, 2025
Shenzhen Zhenxing Ruitong Technology Co., Ltd.CN101Oct 17, 2025Oct 17, 2025
Shenzhen Mlay Intelligent Technology Co., , Ltd.CN101Aug 14, 2025Aug 14, 2025
Su-Ko Technologies, LLCUS101Oct 29, 2025Oct 29, 2025
SZ KKS Silicone&Electronic Co., Ltd.CN101Feb 12, 2026Feb 12, 2026
The Beauty Tech Group, Ltd.GB101Jun 3, 2026Jun 3, 2026
Touchbeauty Beauty & Health ( Shenzhen ) Co., LtdCN101Oct 27, 2025Oct 27, 2025
Ulthera, Inc.US101May 21, 2026May 21, 2026
Weero Co., Ltd.KR101Mar 13, 2026Mar 13, 2026
Woorhi Mechatronics Co., Ltd.KR101May 13, 2026May 13, 2026
Zdeer Technology (Henan) Co., Ltd.CN101Jun 16, 2026Jun 16, 2026
Ziree Co., Ltd.CN101Jun 26, 2026Jun 26, 2026
Acotec Scientific Co., Ltd.CN011Oct 7, 2025Oct 7, 2025
Aerin Medical, Inc.US011May 18, 2026May 18, 2026
Applied Medical Resources Corp.US011Nov 4, 2025Nov 4, 2025
Applied Medical Resources CorporationUS011Oct 31, 2025Oct 31, 2025
Ascblue CorporationUS011Apr 10, 2026Apr 10, 2026
Asterasys Co., Ltd.KR011Oct 16, 2025Oct 16, 2025
Atraverse Medical, Inc.US011Aug 12, 2025Aug 12, 2025
Aventix Medical, Inc.US011Mar 27, 2026Mar 27, 2026
Baylis Medical Technologies, Inc.CA011Oct 28, 2025Oct 28, 2025
Beijing Sano Laser S&T Development Co.,LtdCN011Jun 4, 2026Jun 4, 2026
Beijing Superlaser Technology Co., Ltd.CN011Sep 3, 2025Sep 3, 2025
Bellamia Technologies, Inc.US011Oct 8, 2025Oct 8, 2025
C.R. Bard, Inc.US011Mar 17, 2026Mar 17, 2026
CAO Group, Inc.US011Mar 11, 2026Mar 11, 2026
Changsha Anxiang Medical Technology Co., Ltd.CN011Jul 30, 2025Jul 30, 2025
Classys, Inc.KR011Nov 20, 2025Nov 20, 2025
Cnc TechnologiesKR011Aug 11, 2025Aug 11, 2025
Cynosure Lutronic Technology CorporationKR011Jun 29, 2026Jun 29, 2026
Cynosure, LLCUS011Jun 17, 2026Jun 17, 2026
Dawell Medical, LLCUS011Oct 14, 2025Oct 14, 2025
Ddc Technologies, Inc.US011Apr 22, 2026Apr 22, 2026
Elesta S.P.AIT011Mar 17, 2026Mar 17, 2026
Enamel PureUS011May 29, 2026May 29, 2026
Eufoton S.R.L.IT011May 29, 2026May 29, 2026
Guangzhou Longest Medical Technology Co., Ltd.CN011Dec 9, 2025Dec 9, 2025
Gyrus Acmi, Inc.US011Mar 2, 2026Mar 2, 2026
Haidari Beauty Technology (Beijing) Co., Ltd.CN011Mar 3, 2026Mar 3, 2026
Heager GmbHDE011Aug 26, 2025Aug 26, 2025
Hologic, Inc.US011Jun 17, 2026Jun 17, 2026
Ibramed Equipamentos MédicosBR011Sep 19, 2025Sep 19, 2025
Inbella Medical , Ltd.CA011Jul 25, 2025Jul 25, 2025
InMode , Ltd.IL011Jan 15, 2026Jan 15, 2026
Ipg Medical CorporationUS011Sep 19, 2025Sep 19, 2025
Jeisys Medical IncorporatedKR011Oct 3, 2025Oct 3, 2025
Lagis Enterprise Co., Ltd.TW011May 20, 2026May 20, 2026
Leaseir Technologies, SluES011May 4, 2026May 4, 2026
Livsmed, Inc.KR011Oct 21, 2025Oct 21, 2025
Lumenis Be, Ltd.IL011Jun 2, 2026Jun 2, 2026
Medtronic Sofamor Danek USA, Inc.US011Jun 5, 2026Jun 5, 2026
Menovex Medical Technology (Shenzhen) Co., Ltd.CN011Nov 4, 2025Nov 4, 2025
Motive Health, Inc.US011Nov 6, 2025Nov 6, 2025
Neurent Medical , Ltd.IE011Jun 16, 2026Jun 16, 2026
Olympus Medical Systems Corp.JP011Jul 1, 2026Jul 1, 2026
Olympus Medical Systems CorporationJP011Oct 7, 2025Oct 7, 2025
Olympus Winter & Ibe GmbHDE011Sep 23, 2025Sep 23, 2025
ORO Co., Ltd.KR011Feb 26, 2026Feb 26, 2026
Patriot Laser, LLCUS011Oct 27, 2025Oct 27, 2025
Plasma Surgical, Inc.US011Apr 10, 2026Apr 10, 2026
Prana SurgicalUS011Apr 1, 2026Apr 1, 2026
Risu Medical Technology Co., Ltd.CN011Oct 23, 2025Oct 23, 2025
Sciton, IncUS011Dec 19, 2025Dec 19, 2025
Sejong Medical Co., Ltd.KR011Jun 9, 2026Jun 9, 2026
Senbitec Co., Ltd.KR011Oct 3, 2025Oct 3, 2025
ShenB Co., Ltd.KR011Apr 10, 2026Apr 10, 2026
Shenzhen Gsd Technology Co., Ltd.CN011Feb 6, 2026Feb 6, 2026
Shenzhen Lifotronic Technology Co., Ltd.CN011Jul 30, 2025Jul 30, 2025
Shenzhen Peninsula Medical GroupCN011Jan 30, 2026Jan 30, 2026
Single Pass, Inc.US011Feb 24, 2026Feb 24, 2026
Soniquence, LLCUS011Jan 27, 2026Jan 27, 2026
Stryker InstrumentsUS011Sep 9, 2025Sep 9, 2025
Stryker Sustainability SolutionsUS011Jun 18, 2026Jun 18, 2026
Sutter Medizintechnik GmbHDE011Feb 11, 2026Feb 11, 2026
Syrma Johari Medtech LimitedIN011Aug 28, 2025Aug 28, 2025
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.CN011Aug 29, 2025Aug 29, 2025
Venclose, Inc.US011Aug 19, 2025Aug 19, 2025
Venus Concept, Inc.US011Nov 6, 2025Nov 6, 2025
Vydence Medical Industria E Commercio LtdaBR011Jan 24, 2026Jan 24, 2026
Weifang Mingliang Electronics Co., Ltd.CN011Apr 15, 2026Apr 15, 2026
Wingderm Electro-Optics , Ltd.CN011Feb 24, 2026Feb 24, 2026
Wontech Co., Ltd.KR011Dec 19, 2025Dec 19, 2025
Wuhan Dimed Laser Technology Co., Ltd.CN011Sep 25, 2025Sep 25, 2025
Xi'An Taibo Electronic Technology Co., Ltd.CN011Feb 3, 2026Feb 3, 2026
Zhejiang shuyou Surgical Instrument Co., Ltd.CN011Apr 7, 2026Apr 7, 2026
Zimmer Medizinsysteme GmbHDE011Jan 16, 2026Jan 16, 2026

Applicant names are unnormalised FDA strings: one company filing under two spellings appears twice.

Most active filers, year by year

8 years · top 12 eachmethod →

The most active 510(k) applicants in each year of the tracked codes, with each one's share of that year's total.

YearRank that yearApplicantClearancesShare of that year
20261Shenzhen Kaiyan Medical Equipment Co., Ltd.65.5%
20262Boston Aesthetics, Inc.43.6%
20263Guangdong Newdermo Biotech Co., Ltd.32.7%
20264Shenzhen Ulike Smart Electronics Co., Ltd.32.7%
20265ArthroCare Corporation21.8%
20266BTL Industries, Inc.21.8%
20267Beijing HuaCheng Taike Technology Co., Ltd.21.8%
20268Entire Medical , Ltd.21.8%
20269Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.21.8%
202610Nanjing Bestview Laser S&T Co., Ltd.21.8%
202611Sanhe Meditech Co., Ltd.21.8%
202612Shanghai Apolo Medical Technology Co., Ltd.21.8%
20251Shenzhen Kaiyan Medical Equipment Co., Ltd.114.3%
20252Wontech Co., Ltd.83.1%
20253Shenzhen Ulike Smart Electronics Co., Ltd.72.7%
20254Zhengzhou PZ Laser Slim Technology Co., Ltd.52.0%
20255Changsha Anxiang Medical Technology Co., Ltd.41.6%
20256Erbe Elektromedizin GmbH41.6%
20257Agnes Medical Co., Ltd.31.2%
20258Alma Lasers, Inc.31.2%
20259El.En S.P.A.31.2%
202510Erchonia Corporation31.2%
202511Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.31.2%
202512Inbella Medical, Inc.31.2%
20241Shenzhen Ulike Smart Electronics Co., Ltd.83.5%
20242Wontech Co., Ltd.73.1%
20243El.En S.P.A.62.6%
20244Foreo, Inc.41.7%
20245InMode , Ltd.41.7%
20246Shenzhen Kaiyan Medical Equipment Co., Ltd.41.7%
20247Asclepion Laser Technologies GmbH31.3%
20248Beijing Adss Development Co., Ltd.31.3%
20249Pollogen, Ltd.31.3%
202410Rhein Laser Technologies Co., Ltd.31.3%
202411Wuhan Pioon Technology Co., Ltd.31.3%
202412BTL Industries, Inc.20.9%
20231Light Tree Ventures Europe B.V.62.8%
20232Sofwave Medical, Ltd.52.3%
20233Apyx Medical Corporation31.4%
20234Bios S.R.L.31.4%
20235El.En S.P.A.31.4%
20236Hebei Zhemai Technology Co., Ltd.31.4%
20237Hg Innovations, Ltd.31.4%
20238Livsmed, Inc.31.4%
20239Shanghai Omni Laser Skinology Co., Ltd.31.4%
202310Termosalud31.4%
202311Wontech Co., Ltd.31.4%
202312Alma Lasers, Inc.20.9%
20221Ilooda Co,., Ltd.42.0%
20222Beijing Globalipl Development Co., Ltd.31.5%
20223Conmed Corporation31.5%
20224Cutera, Inc.31.5%
20225Light Tree Ventures Europe B.V.31.5%
20226Pulse Biosciences, Inc.31.5%
20227Venus Concept USA, Inc.31.5%
20228Wontech Co., Ltd.31.5%
20229AVAVA, Inc.21.0%
202210Asclepion Laser Technologies GmbH21.0%
202211BTL Industries, Inc.21.0%
202212Canadian Pioneer Medical Technology Corporation (Cpmt Laser)21.0%
20211El.En Electronic Engineering Spa53.0%
20212Shenzhen Kaiyan Medical CO , Ltd.42.4%
20213Bolder Surgical, LLC31.8%
20214Luvo Medical Technologies, Inc.31.8%
20215ShenB Co., Ltd.31.8%
20216Soliton, Inc.31.8%
20217Btl21.2%
20218Canadian Pioneer Medical Technology Corporation21.2%
20219Candela Corporation21.2%
202110Covidien, LLC21.2%
202111Dannik, LLC21.2%
202112Eclipse Medcorp, LLC21.2%
20201Quanta System Spa53.2%
20202Shanghai Apolo Medical Technology Co., Ltd.53.2%
20203Lumenis, Ltd.42.6%
20204Fotona D.O.O.31.9%
20205Livsmed, Inc.31.9%
20206New Deantronics Taiwan , Ltd.31.9%
20207Venus Concept USA, Inc.31.9%
20208Viora , Ltd.31.9%
20209Aesculap, Inc.21.3%
202010Applied Medical Resources Corp.21.3%
202011Beijing Lead Beauty S & T Co., Ltd.21.3%
202012Beijing Superlaser Technology Co., Ltd.21.3%
20191New Deantronics Taiwan , Ltd.42.7%
20192CAO Group, Inc.32.1%
20193Cyden Limited32.1%
20194Erbe Elektromedizin GmbH32.1%
20195Inmode MD , Ltd.32.1%
20196Quanta System Spa32.1%
20197Shanghai Apolo Medical Technology Co., Ltd.32.1%
20198Venus Concept USA, Inc.32.1%
20199Wontech Co., Ltd.32.1%
201910ArthroCare Corporation21.4%
201911BTL Industries, Inc.21.4%
201912Beijing Superlaser Technology Co., Ltd.21.4%

This is the top 12 per year, not every filer — the source fetch counted the rest as one number.