Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 40
- Latest Decision
- 2018-09-26
Clearances · page 31 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182325 | InMode RF System | Inmode MD , Ltd. | GEI | Class II | 2018-09-26 |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) | Health Beacons, Inc. | NEU | Class II | 2018-09-25 |
| K180338 | Cellulize | Ward Photonics, LLC | OLI | Class II | 2018-09-21 |
| K181200 | AEROmini Tracheobronchial Stent System | Merit Medical Systems, Inc. | JCT | Class II | 2018-09-21 |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | ESW | Class II | 2018-09-21 |
| K182340 | NICO Myriad | Nico Corporation | GEI | Class II | 2018-09-20 |
| K181734 | Beurer IPL 8500 device/ IPL VelvetSkin Pro | Home Well Trading, Ltd. | OHT | Class II | 2018-09-19 |
| K180894 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2018-09-19 |
| K181620 | Endoscopic Linear Cutting Staplers and Loading Units for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. | GDW | Class II | 2018-09-18 |
| K181320 | Caprolon | Resorba Medical GmbH | GAM | Class II | 2018-09-18 |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC | GDW | Class II | 2018-09-18 |
| K181632 | Venacure 1470 Pro | Quanta System Spa | GEX | Class II | 2018-09-17 |
| K173827 | LightScalpel | Lightscalpel, LLC | GEX | Class II | 2018-09-14 |
| K173676 | A-FIT | Hironic Co., Ltd. | GEX | Class II | 2018-09-14 |
| K180875 | POLY REJUV | Medtek Skincare, LLC | OHS | Class II | 2018-09-14 |
| K181568 | IPL Salon Hair Reduction System | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt | OHT | Class II | 2018-09-11 |
| K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | LEJ | Class II | 2018-09-10 |
| K181211 | Human Tecar HCR 1002 | Unibell S.R.L | PBX | Class II | 2018-09-10 |
| K182053 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | PQM | Class II | 2018-09-07 |
| K180778 | Exceed Microneedling Device | Mt. Derm GmbH | QAI | Class II | 2018-09-07 |
| K173813 | IPL Hair Removal Device Joy Version | Shen Zhen Cosbeauty Co., Ltd. | OHT | Class II | 2018-09-07 |
| K181518 | Sebacia Microparticles | Sebacia, Inc. | QCY | Class II | 2018-09-06 |
| K181662 | Iridex TruFocus LIO Premiere | Iridex Corporation | GEX | Class II | 2018-09-05 |
| K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | GEI | Class II | 2018-09-04 |
| K181510 | ECHOLASER X4 | El.En Electronic Engineering Spa | GEX | Class II | 2018-09-04 |
| K180888 | LYFT | Uplevity, Inc. | OLP | Class II | 2018-08-30 |
| K181486 | DEKA Motus AY | El.En Electronic Engineering Spa | GEX | Class II | 2018-08-30 |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | OOK | Class II | 2018-08-29 |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | NEW | Class II | 2018-08-27 |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2018-08-21 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | OXC | Class II | 2018-08-17 |
| K182067 | PleuraFlow System with FlowGlide Extra Drainage Length | Clearflow, Inc. | OTK | Class II | 2018-08-14 |
| K173407 | VT - 100, VT - 200 | Carilex Medical, Inc. | OMP | Class II | 2018-08-09 |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. | KGO | Class I | 2018-08-08 |
| K181182 | DYNACORD Suture | Medos International SARL | GAT | Class II | 2018-08-02 |
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | NEU | Class II | 2018-08-02 |
| K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | FTL | Class II | 2018-08-02 |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | Medtronic Advanced Energy | GEI | Class II | 2018-08-02 |
| K181480 | MMD Tip | Strata Skin Sciences, Inc. | GEX | Class II | 2018-08-01 |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | Ceterix Orthopaedics, Inc. | GAT | Class II | 2018-08-01 |
| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | 3M Healthcare | FXX | Class II | 2018-07-31 |
| DEN180008 | MolecuLight i:X | MolecuLight, Inc. | QCR | Class I | 2018-07-31 |
| K181272 | Picocare Family | Wontech Co., Ltd. | GEX | Class II | 2018-07-31 |
| K181741 | IceSphere 1.5 CX Cryoablation Needle | Galil Medical , Ltd. | GEH | Class II | 2018-07-30 |
| K172273 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | FTC | Class II | 2018-07-30 |
| K181431 | Laser Ureteral Catheter | Cook Incorporated | GEX | Class II | 2018-07-30 |
| K181268 | PROLENE (Polypropylene) 3D Patch | ETHICON, Inc. | FTL | Class II | 2018-07-26 |
| K181659 | Avologi ENEO | Premier North America, Inc. | OHS | Class II | 2018-07-26 |
| K180115 | TWBM Pump | Taiwan Biomaterial Co., Ltd. | JCX | Class II | 2018-07-24 |
| K181095 | RF-Relief | El Global Trade, Ltd. | PBX | Class II | 2018-07-24 |
| K180518 | GME LinScan Lite 808 Laser System | Gme German Medical Engineering GmbH | GEX | Class II | 2018-07-23 |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | JCX | Class II | 2018-07-23 |
| K170369 | Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. | GEI | Class II | 2018-07-19 |
| K172389 | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | FZD | Class II | 2018-07-18 |
| K181019 | Diode Laser System | Guangzhou Huafei Tongda Technology Co., Ltd. | GEX | Class II | 2018-07-16 |
| K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | GEI | Class II | 2018-07-13 |
| K171550 | Sterile Latex Surgical Gloves, Powder Free | Sanrea Healthcare Products Pvt, Ltd. | KGO | Class I | 2018-07-13 |
| K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | FYA | Class II | 2018-07-13 |
| K180575 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X | Olympus Medical Systems Corp. | GEI | Class II | 2018-07-12 |
| K181523 | Syneron CO2RE System | Syneron-Candela Corp | GEX | Class II | 2018-07-11 |
| K180967 | Dental Diode Laser System | Lazon Medical Laser Co., Ltd. | GEX | Class II | 2018-07-11 |
| K180900 | LED Light Therapy Device | Uvbiotek, LLC | OLP | Class II | 2018-07-10 |
| K173359 | Fractional CO2 Surgical Laser System | Ami, Inc. | GEX | Class II | 2018-07-05 |
| K181044 | 400um Perforator and Accessory Vein Ablation Kit | AngioDynamics, Inc. | GEX | Class II | 2018-07-05 |
| K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | ETHICON, Inc. | FTL | Class II | 2018-07-02 |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | PZX | Class II | 2018-06-28 |
| K180993 | Beacon Advanced CO2 Laser System | Omniguide, Inc. | GEX | Class II | 2018-06-28 |
| K181121 | Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro | Home Well Trading, Ltd. | OHT | Class II | 2018-06-28 |
| K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh | ETHICON, Inc. | FTL | Class II | 2018-06-28 |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | GAP | Class II | 2018-06-25 |
| K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | LEJ | Class II | 2018-06-22 |
| K151721 | FIJI SUN FLUORESCENT TANNING UNIT | Kdb Inc. (Dba) Sperti Sunlamp | LEJ | Class II | 2018-06-22 |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Covidien | GEI | Class II | 2018-06-21 |
| K173700 | PICOPLUS Laser System | Lutronic Corporation | GEX | Class II | 2018-06-19 |
| K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Covidien | GEI | Class II | 2018-06-19 |
| K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | OHS | Class II | 2018-06-19 |
| K180847 | Neutrogena Light Therapy Acne Mask+ | Johnson & Johnson Consumer, Inc. | OLP | Class II | 2018-06-19 |
| K172954 | Medline Prevention CoolZone Gown | Medline Industries, Inc. | FYA | Class II | 2018-06-15 |
| K180719 | InMode Diolaze System | Inmode MD , Ltd. | GEX | Class II | 2018-06-14 |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | ONF | Class II | 2018-06-13 |
| K173503 | Pollogen Legend System | Pollogen, Ltd. | GEI | Class II | 2018-06-11 |
| K172725 | VT Dressing Kits | Carilex Medical, Inc. | OMP | Class II | 2018-06-08 |
| K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | FTL | Class II | 2018-06-07 |
| K172909 | ELEVARE, PERFECTIO 4 | Omm Imports D/B/A Zero Gravity | OHS | Class II | 2018-06-07 |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | PMC | Class II | 2018-06-07 |
| K180621 | EchoMark, EchoMark LP | Sonavex, Inc. | NEU | Class II | 2018-06-06 |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. | PBX | Class II | 2018-06-06 |
| K180593 | Vbeam Prima Laser System | Syneron-Candela | GEX | Class II | 2018-06-05 |
| K180191 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | GAT | Class II | 2018-06-05 |
| K180640 | SmartClip Soft Tissue Marker | Elucent Medical, Inc. | NEU | Class II | 2018-06-04 |
| K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | OLP | Class II | 2018-06-04 |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | Kci USA, Inc. | OMP | Class II | 2018-06-01 |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD , Ltd. | GEI | Class II | 2018-06-01 |
| K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | BTA | Class II | 2018-05-31 |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | MUU | Class II | 2018-05-25 |
| K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | Ethicon Endo-Surgery, LLC | GEI | Class II | 2018-05-23 |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC | GEI | Class II | 2018-05-22 |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | FYD | Class II | 2018-05-18 |
| K180508 | JOULE SYSTEM | Sciton, Inc | GEX | Class II | 2018-05-18 |
| K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | PGZ | Class II | 2018-05-18 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.