Newest FDA clearances in medical aesthetics
Updated Jul 26, 2026
Every 510(k) decision in the tracked aesthetic product codes for the whole fetch window, month by month.
231Decisions in the window2025-07-25 to 2026-07-25
93From narrow aesthetic codes
138From broad, mixed-use codestagged on every row
44In the last 90 days
Counts of 510(k) clearances inside the fetch window (2025-07-25 to 2026-07-25) — clearances, not approvals, and not the full history of these product codes. What this measuresThese are 510(k) CLEARANCES, not approvals, and the window is the fetch window (2025-07-25 to 2026-07-25) — not the whole history of the product codes. A 510(k) clearance means FDA agreed the device is substantially equivalent to one already legally on the market; it is not a finding that the device is effective and not a ranking against any other product. Narrow aesthetic codes are the curated product codes; the broad, mixed-use codes (GEX, GEI, NGX) also carry non-aesthetic devices, so those rows are tagged rather than silently counted as aesthetic and have not been individually vetted. Every count on this strip is a count of FDA decision records, nothing more.
Methodology →
Jul 2026
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 applicantApplicantThe company named on an FDA submission, which can be the maker, its parent company or the distributor that sells the device., its category and the product codeProduct codeA three-letter FDA code naming a type of device rather than a brand, so every submission for that type of device carries the same code. it was filed under. 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. — a 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., which means cleared, not approved — and it opens that record on openFDAopenFDAThe FDA's own public data service, which is where every clearance record on this site comes from.. A row tagged “Broad code” came from GEX, GEI or NGX, which also carry non-aesthetic devices.
- Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · RF & Microneedling · PBX
- ChromixTermosalud S.L. · Lasers & Light · OHS
- 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 & Microneedling · GEI
No rows in this category.
Jun 2026
- LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd. · Lasers & Light · OHS
- LUTRONIC GENIUSCynosure Lutronic Technology Corporation · RF & Microneedling · GEI
- Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd. · RF & Microneedling · GEI
- 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 & Light · OAP
- 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 & Light · GEX
- LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. · Lasers & Light · OHS
- Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions · RF & Microneedling · GEI
- PICOSURE WORKSTATIONCynosure, LLC · Lasers & Light · GEX
- CoolSeal Generator® (CSL-200-90)Hologic, Inc. · RF & Microneedling · GEI
- NEUROMARK System (NMK00301)Neurent Medical , Ltd. · RF & Microneedling · GEI
- Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd. · Lasers & Light · OAP
- LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OHS
- 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 & Light · OAP
- Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd. · Lasers & Light · ONF
- LAP-iX2NSejong Medical Co., Ltd. · RF & Microneedling · GEI
- OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc. · RF & Microneedling · GEI
- Alma TED+ SystemAlma Lasers, Inc. · Lasers & Light · OAP
- LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,Ltd · Lasers & Light · GEX
- CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · Lasers & Light · OHS
- Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC · RF & Microneedling · GEI
- MILAN SystemLumenis Be, Ltd. · RF & Microneedling · GEI
No rows in this category.
May 2026
- ENTire IRE SystemEntire Medical , Ltd. · RF & Microneedling · GEI
- LASEmaR 1500Eufoton S.R.L. · Lasers & Light · GEX
- LUNE PureHygieneEnamel Pure · Lasers & Light · GEX
- VIVA combo RF SystemStarmed Co., Ltd. · RF & Microneedling · GEI
- 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 & Light · OHT
- Ulthera® SystemUlthera, Inc. · Body Contouring · OHV
- Boston 2910 (Boston 2910)Boston Aesthetics, Inc. · Lasers & Light · GEX
- 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 & Light · OHT
- LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)Lagis Enterprise Co., Ltd. · RF & Microneedling · GEI
- RhinAer+ StylusAerin Medical, Inc. · RF & Microneedling · GEI
- MOSES RaydarBoston Scientific Corporation · Lasers & Light · GEX
- Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd. · RF & Microneedling · QAI
- myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V. · Lasers & Light · OHS
- PICO SHINING (PICO-K; PICOFY)Speclipse, Inc. · Lasers & Light · GEX
- CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd. · Lasers & Light · GEX
- 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 & Light · OHT
- Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Body Contouring · OLI
- Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd. · Lasers & Light · GEX
- Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Leaseir Technologies, Slu · Lasers & Light · GEX
No rows in this category.
Apr 2026
- YellowStarAsclepion Laser Technologies GmbH · Lasers & Light · GEX
- LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)NOOANCE · Lasers & Light · OHS
- VANISH PRODdc Technologies, Inc. · Lasers & Light · GEX
- IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)Shenzhen Semlamp Intelligent Technology Co., Ltd. · Lasers & Light · OHT
- Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd. · Lasers & Light · GEX
- Diode Laser Therapy Systems (V19)Weifang Mingliang Electronics Co., Ltd. · Lasers & Light · GEX
- Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · Body Contouring · OLI
- DiacoreShenB Co., Ltd. · Body Contouring · NGX
- ARION ARC SystemPlasma Surgical, Inc. · RF & Microneedling · GEI
- Ascblue (8010)Ascblue Corporation · RF & Microneedling · GEI
- Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd. · Lasers & Light · GEX
- Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)Zhejiang shuyou Surgical Instrument Co., Ltd. · RF & Microneedling · GEI
- SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · RF & Microneedling · GEI
- SPECCHIOEl.En S.P.A. · RF & Microneedling · PBX
- Prana SystemPrana Surgical · RF & Microneedling · GEI
No rows in this category.
Mar 2026
- Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd. · Lasers & Light · GEX
- FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · RF & Microneedling · GEI
- CO2 Laser SystemSanhe Meditech Co., Ltd. · Lasers & Light · GEX
- AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc. · RF & Microneedling · GEI
- LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · RF & Microneedling · GEI
- LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. · Lasers & Light · OHS
- LASER THERMAL THERAPY KITElesta S.P.A · Lasers & Light · GEX
- BTL-785NEHBTL Industries, Inc. · RF & Microneedling · GEI
- Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)C.R. Bard, Inc. · Lasers & Light · GEX
- Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd. · Lasers & Light · OHS
- LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd. · Lasers & Light · OHS
- Apollo Quattro (APQ-10M)Weero Co., Ltd. · RF & Microneedling · PBX
- Zionic Pro Max (EMS)Termosalud S.L. · Body Contouring · NGX
- Picasso Pro Diode Laser (002-00460)CAO Group, Inc. · Lasers & Light · GEX
- Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)Shenzhen Chuangtong Yigou Technology Co., Ltd. · Lasers & Light · OHT
- Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTD · Lasers & Light · PDZ
- NeoSculpt PlusS&M Medical Co., Ltd. · RF & Microneedling · PBX
- Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Lasers & Light · GEX
- LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OLP
- CO2 Laser Treatment Machine (CFR3M1)Haidari Beauty Technology (Beijing) Co., Ltd. · Lasers & Light · GEX
- LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd. · Lasers & Light · OHS
- POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc. · RF & Microneedling · GEI
No rows in this category.
Feb 2026
- Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd. · Lasers & Light · GEX
- Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd. · Lasers & Light · GEX
- CAPRIORO Co., Ltd. · Lasers & Light · GEX
- SP Electrocautery Device (SP20)Single Pass, Inc. · RF & Microneedling · GEI
- Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics , Ltd. · Lasers & Light · GEX
- IPL Hair Removal Device (Models: T31A, T32A)Shenzhen Mlay Intelligent Technology Co., Ltd. · Lasers & Light · OHT
- FAQ (LED Panel); FAQ (Dual LED Panel)Foreo, Inc. · Lasers & Light · OHS
- SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc. · RF & Microneedling · QAI
- BTL-754FFBTL Industries, Inc. · Lasers & Light · GEX
- Contour Light (CL-100)Contour Research, LLC · Body Contouring · OLI
- LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)SZ KKS Silicone&Electronic Co., Ltd. · Lasers & Light · OHS
- CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH · RF & Microneedling · GEI
- Dermatrix DuoShenzhen Gsd Technology Co., Ltd. · RF & Microneedling · GEI
- 808nm semiconductor laser hair removal machineXi'An Taibo Electronic Technology Co., Ltd. · Lasers & Light · GEX
No rows in this category.
Jan 2026
- ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group · RF & Microneedling · GEI
- Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)Shenzhen Jianchao Intelligent Technology Co., Ltd. · Lasers & Light · OHS
- Boston PICO (Boston PICO)Boston Aesthetics, Inc. · Lasers & Light · GEX
- HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OHS
- Reusable 3 Button Fingerswitch WandSoniquence, LLC · RF & Microneedling · GEI
- InbellaIgnite RF SystemInbella Medical, Inc. · RF & Microneedling · GEI
- Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Lasers & Light · GEX
- Vydence Family of LasersVydence Medical Industria E Commercio Ltda · Lasers & Light · GEX
- LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)Shenzhen Rainbow Technology Co., Ltd. · Lasers & Light · OHS
- TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OAP
- Boston Pico755Boston Aesthetics, Inc. · Lasers & Light · GEX
- CoolToneZimmer Medizinsysteme GmbH · Body Contouring · NGX
- Ignite RF SystemInMode , Ltd. · RF & Microneedling · GEI
- ENTire IRE SystemEntire Medical , Ltd. · RF & Microneedling · GEI
- Boston iFace (Boston iFace)Boston Aesthetics, Inc. · RF & Microneedling · GEI
- Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · RF & Microneedling · PAY
No rows in this category.
Dec 2025
- Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)Shenzhen Fansizhe Science and Technology Co., Ltd. · Lasers & Light · OHT
- LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)Shenzhen Saidi Light Therapy Technology Co., Ltd. · Lasers & Light · OHS
- Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V. · Lasers & Light · OAP
- PICO-KSpeclipse, Inc. · Lasers & Light · GEX
- Feather/numiere 05 06 07 (05)Heat IN A Click, LLC · Lasers & Light · OHS
- Philips Lumea IPLPhilips Consumer Lifestyle B.V. · Lasers & Light · OHT
- LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)Dongguan Yijiaming Technology Co., Ltd. · Lasers & Light · OHS
- LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd. · Lasers & Light · OHS
- LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · Lasers & Light · OHS
- SANDRO DualWontech Co., Ltd. · Lasers & Light · GEX
- JOULE 1064nm System and AccessoriesSciton, Inc · Lasers & Light · GEX
- CO2 Laser Therapy System (Model: LFS-D9U)Sanhe Lefis Electronics Co., Ltd. · Lasers & Light · GEX
- MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH · RF & Microneedling · GEI
- Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd. · Lasers & Light · OHS
- Erchonia CLX (Model # CFL)Erchonia Corporation · Body Contouring · OLI
- Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)Micro-Energy Medical Technology Co., Ltd. · Lasers & Light · GEX
- Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd. · Body Contouring · NGX
- LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)Guangdong Ace-Tec Co., Ltd. · Lasers & Light · OHS
- Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)Shenzhen Siken 3D Technology Development Co., Ltd. · Lasers & Light · OHS
- Aura WaveAura Wellness, LLC · Body Contouring · SGT
- Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited. · Body Contouring · OLI
No rows in this category.
Nov 2025
- Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd. · Lasers & Light · GEX
- BELLUS-QSpeclipse, Inc. · Lasers & Light · GEX
- IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd. · Lasers & Light · OHT
- LeafPure-Echo (LM-LPNdA)Shenzhen Leaflife Technology Co., Ltd. · Lasers & Light · GEX
- Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Lasers & Light · GEX
- Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Lasers & Light · GEX
- F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · RF & Microneedling · GEI
- CuRAS hybridClassys, Inc. · Lasers & Light · GEX
- Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Lasers & Light · GEX
- LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd. · Lasers & Light · OHS
- IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd. · Lasers & Light · OHT
- Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd. · Lasers & Light · OHS
- TS-RF Generator (STS10)Starmed Co., Ltd. · RF & Microneedling · GEI
- IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co. , Ltd. · Lasers & Light · OHT
- LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd. · Lasers & Light · OHS
- Medical Diode Laser Systems (VeinCure)Baoding Te'Anzhou Electronic Technology Co., Ltd. · Lasers & Light · GEX
- CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd · Lasers & Light · GEX
- Motive Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc. · Body Contouring · NGX
- Venus Nova (FP-2001)Venus Concept, Inc. · RF & Microneedling · GEI
- Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd · Lasers & Light · GEX
- Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp. · RF & Microneedling · GEI
- Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd. · Lasers & Light · GEX
No rows in this category.
Oct 2025
- Diode Laser Hair Removal Machine (GLD01)Sanhe Meditech Co., Ltd. · Lasers & Light · GEX
- Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation · RF & Microneedling · GEI
- ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc. · RF & Microneedling · QAI
- Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)Boston Scientific Corporation · Lasers & Light · GEX
- Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OAP
- SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC · RF & Microneedling · QAI
- PrecisePath Radiofrequency Puncture Generator and PrecisePath FootswitchBaylis Medical Technologies, Inc. · RF & Microneedling · GEI
- VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd · Lasers & Light · OHS
- Patriot DuoPatriot Laser, LLC · Lasers & Light · GEX
- MultiPulse TFLAsclepion Laser Technologies GmbH · Lasers & Light · GEX
- 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd. · Lasers & Light · GEX
- Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd. · Lasers & Light · GEX
- Hair Growth Laser CapCosmo Far East Technology Limited · Lasers & Light · OAP
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc. · RF & Microneedling · GEI
- Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd. · Lasers & Light · GEX
- AVAVA Skin Treatment SystemAVAVA, Inc. · Lasers & Light · ONG
- MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)Shenzhen Zhenxing Ruitong Technology Co., Ltd. · Lasers & Light · OHS
- Light Therapy Mask (1019055)Merchsource, LLC · Lasers & Light · OHS
- CoolfaseAsterasys Co., Ltd. · RF & Microneedling · GEI
- InbellaMulti SystemInbella Medical, Inc. · RF & Microneedling · GEI
- IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)Shenzhen Qiaochengli Technology Co., Ltd. · Lasers & Light · OHT
- Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC · Lasers & Light · GEX
- GENEO X ELITEPollogen, Ltd. · RF & Microneedling · PAY
- IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd. · Lasers & Light · OHT
- ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OHS
- The Botticelli (Model: Athena)Bellamia Technologies, Inc. · Lasers & Light · GEX
- Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)Olympus Medical Systems Corporation · RF & Microneedling · GEI
- Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)Acotec Scientific Co., Ltd. · RF & Microneedling · GEI
- TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated · Lasers & Light · GEX
- HESTIA (L200-A)Senbitec Co., Ltd. · Lasers & Light · GEX
- IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd. · Lasers & Light · OHT
- Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,Shenzhen Ulike Smart Electronics Co., Ltd. · Lasers & Light · OHT
- Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd. · Lasers & Light · GEX
- Light Therapy Decollete Mask (1019135)Merchsource, LLC · Lasers & Light · OHS
- E BlatorNew Deantronics Taiwan , Ltd. · RF & Microneedling · GEI
- Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd. · Lasers & Light · OHS
No rows in this category.
Sep 2025
- NEW DOUBLO 2.0Hironic Co., Ltd. · RF & Microneedling · GEI
- Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd. · Lasers & Light · GEX
- Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)Wuhan Dimed Laser Technology Co., Ltd. · Lasers & Light · GEX
- Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc. · Lasers & Light · GEX
- Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)Olympus Winter & Ibe GmbH · RF & Microneedling · GEI
- IPGTFL-02Ipg Medical Corporation · Lasers & Light · GEX
- VEGAIbramed Equipamentos Médicos · Lasers & Light · GEX
- IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)Miley Technology (Hebei) Co., Ltd. · Lasers & Light · OHT
- Legend X PlatformPollogen, Ltd. · RF & Microneedling · GEI
- LED Light Therapy Mask (2311, 2344, 2457, 2458)Dongguan Yanxi Technology Co., Ltd. · Lasers & Light · OHS
- Erchonia EVRLErchonia Corporation · Lasers & Light · OLP
- OptiLUV DevicePollogen, Ltd. · RF & Microneedling · PBX
- PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · RF & Microneedling · GEI
- KALA MINI 2.0 (KALA-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OHS
- Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd. · Lasers & Light · ONF
- Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd. · Lasers & Light · GEX
- AGNES UltraAgnes Medical Co., Ltd. · RF & Microneedling · GEI
- MEDILIGHTMedicreations, LLC · Lasers & Light · ONF
No rows in this category.
Aug 2025
- GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · Lasers & Light · GEX
- Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · RF & Microneedling · GEI
- truFlexSyrma Johari Medtech Limited · Body Contouring · NGX
- Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH · Lasers & Light · GEX
- PRO Pen Microneedling System (6883)Dermalogica, LLC · RF & Microneedling · QAI
- LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · Lasers & Light · OHS
- Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc. · RF & Microneedling · GEI
- Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)Agnes Medical Co., Ltd. · RF & Microneedling · GEI
- FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · Lasers & Light · OHS
- IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)Shenzhen Mlay Intelligent Technology Co., , Ltd. · Lasers & Light · OHT
- TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · Lasers & Light · OHS
- WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd. · RF & Microneedling · PBX
- HOTWIRE System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · RF & Microneedling · GEI
- Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)Cnc Technologies · RF & Microneedling · GEI
- XERFLutronic Corporation · RF & Microneedling · GEI
- Diode laser device (BM091)Hebei Newangie Technology Co., Ltd. · Lasers & Light · GEX
- LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd. · Lasers & Light · OHS
- OloEl.En S.P.A. · Lasers & Light · GEX
- IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial Co., Ltd. · Lasers & Light · OHT
No rows in this category.
Jul 2025
- eCO2 3DLutronic Corporation · Lasers & Light · ONG
- TENS and EMS UnitChangsha Anxiang Medical Technology Co., Ltd. · Body Contouring · NGX
- Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd. · Lasers & Light · GEX
- InbellaMAX SystemInbella Medical , Ltd. · RF & Microneedling · GEI
- Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)Zhengzhou PZ Laser Slim Technology Co., Ltd. · Lasers & Light · GEX
No rows in this category.
510(k) decisions in the aesthetic product codes we track — filings, not sales, safety or efficacy. What this measuresCount of FDA 510(k) clearance decisions whose product code is on the Dalphene aesthetic allowlist. A clearance means FDA agreed the device is substantially equivalent to a legally marketed predicate. It is NOT an approval, NOT a measure of efficacy, NOT a measure of safety, and NOT a measure of sales. Manufacturers file multiple 510(k)s for the same platform (new applicators, new indications, new software), so clearance counts track filing activity, not the number of distinct products. Rows with code_breadth = 'broad_mixed' come from product codes (GEX, GEI, NGX) that also carry non-aesthetic devices. They are included because most real aesthetic platforms are cleared under them -- but they also pull in things like general-surgery electrosurgical generators and lithotripsy lasers that no med spa would ever buy. These rows have NOT been individually vetted as aesthetic. The UI should default to the narrow-code counts and offer the broad view as an explicit, labelled opt-in. Any chart that mixes them must say so on the chart. This page is the complete feed: all 231 decisions FDA published in the tracked codes between 2025-07-25 and 2026-07-25, in every month of the window, with nothing trimmed. 138 came from the broad codes and are tagged “Broad code” rather than quietly deleted. 9 of the 231 rows carry a K-number that is also one of the records crosswalked to a product page in this index and link to it; the rest are real clearances for products this index does not card, and they are shown anyway. Injectables and topicals are absent from this feed by construction, not by omission: they reach the market through PMA, BLA or NDA approval, not 510(k) clearance, so no 510(k) query can return them and no category chip for them is offered. The first and last months of the window are partial by construction — the window opened mid-Jul 2025 and closes mid-Jul 2026 — so their totals are not comparable with a full month. FDA also publishes to its releasable database on a lag, so the newest month always undercounts.
Methodology →