Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 39
- Latest Decision
- 2026-09-30
Clearances · page 1 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261975 | Braun Aura 7 (6041) | CyDen Limited | OHT | Class II | 2026-09-30 |
| K263073 | Fast Absorbing PGLA | Riverpoint Medical, LLC | GAM | Class II | 2026-09-29 |
| K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | FTL | Class II | 2026-09-28 |
| K261543 | Phasix ST Parastomal Hernia Mesh | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT | Class II | 2026-09-28 |
| K261977 | Braun Aura 9 (6042) | Cyden Limited | OHT | Class II | 2026-09-25 |
| K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | GDW | Class II | 2026-09-25 |
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | GEX | Class II | 2026-09-24 |
| K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | PBX | Class II | 2026-09-22 |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | GEX | Class II | 2026-09-19 |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | GEX | Class II | 2026-09-19 |
| K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | OHT | Class II | 2026-09-18 |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | GEX | Class II | 2026-09-18 |
| K254238 | MINT MONO Sutures | Hans Biomed Corporation | NEW | Class II | 2026-09-18 |
| K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | OKO | Class II | 2026-09-18 |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | GEI | Class II | 2026-09-17 |
| K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | PEM | Class II | 2026-09-17 |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-09-17 |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-09-17 |
| K260677 | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | FZP | Class II | 2026-09-17 |
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | GEI | Class II | 2026-09-17 |
| K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | 2026-09-16 |
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | 2026-09-16 |
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | GEI | Class II | 2026-09-15 |
| K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2026-09-13 |
| K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | QPC | Class II | 2026-09-11 |
| K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | OMP | Class II | 2026-09-11 |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | GEI | Class II | 2026-09-11 |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2026-09-10 |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | GEX | Class II | 2026-09-10 |
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | NAD | Class I | 2026-09-10 |
| K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | PEM | Class II | 2026-09-08 |
| K254135 | LipoSurg ARTIST | NOUVAG AG | QPB | Class II | 2026-09-05 |
| K262315 | NeuroBlate System | Monteris Medical | ONO | Class II | 2026-09-03 |
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | GEH | Class II | 2026-09-02 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | GEI | Class II | 2026-09-02 |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-09-02 |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. | QSO | Class II | 2026-09-01 |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | GEX | Class II | 2026-09-01 |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | OHS | Class II | 2026-08-31 |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | NUV | Class II | 2026-08-28 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-08-27 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | GEI | Class II | 2026-08-27 |
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | FYA | Class II | 2026-08-26 |
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | QRK | Class II | 2026-08-25 |
| K253879 | MONOFIX PDO | Samyang Holdings Corporation | NEW | Class II | 2026-08-25 |
| K252535 | Inno-Switch Laparoscopic Instruments | Taiwan Surgical Corporation | GEI | Class II | 2026-08-25 |
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | GAT | Class II | 2026-08-22 |
| K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | Apyx Medical Corporation | QPB | Class II | 2026-08-21 |
| K260817 | MIRA Surgical System | Virtual Incision | SAB | Class II | 2026-08-20 |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | GEX | Class II | 2026-08-19 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | GEX | Class II | 2026-08-19 |
| K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | 2026-08-18 |
| K262135 | Lancing device | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2026-08-18 |
| K262406 | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | FTM | Class II | 2026-08-12 |
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | OAB | Class II | 2026-08-12 |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-08-11 |
| K261398 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2026-08-11 |
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | QPC | Class II | 2026-08-11 |
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | 2026-08-10 |
| K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | OHS | Class II | 2026-08-10 |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | FYA | Class II | 2026-08-07 |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | OHS | Class II | 2026-08-07 |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | OHS | Class II | 2026-08-04 |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | 2026-08-04 |
| K261503 | PuraStat GI | 3-D Matrix, Inc. | QAU | Class II | 2026-08-03 |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | OHS | Class II | 2026-07-31 |
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Hartalega NGC Sdn. Bhd. | KGO | Class I | 2026-07-28 |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | OHS | Class II | 2026-07-24 |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | 2026-07-24 |
| K260804 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | SCV | Class II | 2026-07-22 |
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2026-07-22 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | GEI | Class II | 2026-07-22 |
| DEN250068 | OTTAVA Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | SIR | Class II | 2026-07-21 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | 2026-07-21 |
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | Taiwan Surgical Corporation | FZP | Class II | 2026-07-20 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-07-17 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-07-16 |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. | OHS | Class II | 2026-07-15 |
| K253504 | Volnewmer | Classys, Inc. | GEI | Class II | 2026-07-13 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | FYA | Class II | 2026-07-10 |
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | PBX | Class II | 2026-07-10 |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | ESW | Class II | 2026-07-10 |
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics | PZP | Class II | 2026-07-09 |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | NEW | Class II | 2026-07-09 |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | QRL | Class II | 2026-07-06 |
| K254056 | 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. | GEI | Class II | 2026-07-01 |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | GAT | Class II | 2026-07-01 |
| K261473 | Chromix | Termosalud S.L. | OHS | Class II | 2026-07-01 |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical | GEH | Class II | 2026-06-30 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | GEI | Class II | 2026-06-29 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. | OHS | Class II | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | GEI | Class II | 2026-06-29 |
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | Edwards Lifesciences | PZX | Class II | 2026-06-26 |
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | GAM | Class II | 2026-06-25 |
| K253263 | ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | OMP | Class II | 2026-06-24 |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | OMP | Class II | 2026-06-23 |
| K253211 | AQUABEAM Robotic System | Procept Biorobotics | PZP | Class II | 2026-06-23 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | OHS | Class II | 2026-06-18 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | GEI | Class II | 2026-06-18 |
| K261701 | 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. | GEX | Class II | 2026-06-18 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.