Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 37
- Latest Decision
- 2017-05-22
Clearances · page 35 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | Lumenis, Ltd. | GEX | Class II | 2017-05-22 |
| K160677 | MICRORUPTOR 6 | Meridian AG | GEX | Class II | 2017-05-19 |
| K170908 | PK AIM | Gyrus Acmi, Inc. | GEI | Class II | 2017-05-19 |
| K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | FZP | Class II | 2017-05-19 |
| K171135 | Lipogems System | Lipogems International Spa | MUU | Class II | 2017-05-18 |
| K170500 | SIROLaser Advance+ | Dentsply Sirona | GEX | Class II | 2017-05-16 |
| K163638 | Dental 5 Multi Diode laser | Bio-Med USA, Inc. | GEX | Class II | 2017-05-15 |
| K170370 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | OHV | Class II | 2017-05-15 |
| K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | Spiration, Inc. | GEI | Class II | 2017-05-11 |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | 2017-05-11 |
| K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | GEI | Class II | 2017-05-08 |
| K170111 | Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 | Pulsaderm, LLC | OLP | Class II | 2017-05-08 |
| K170734 | Venus Silk.expert | Cyden Limited | GEX | Class II | 2017-05-08 |
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | AngioDynamics, Inc. | NEY | Class II | 2017-05-05 |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | Hartalega Sdn Bhd | KGO | Class I | 2017-05-05 |
| K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | GEI | Class II | 2017-05-04 |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | Cook Ireland, Ltd. | MUM | Class II | 2017-05-04 |
| K170718 | Iridex TruFocus LIO Premiere | Iridex Corporation | GEX | Class II | 2017-05-03 |
| K170107 | Surgi Max Ultra | Elliquence, LLC | GEI | Class II | 2017-05-03 |
| K170269 | Hee HR Mini | Oriental Inspiration Limited | OHT | Class II | 2017-05-03 |
| K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | GAW | Class II | 2017-05-03 |
| K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | OLC | Class II | 2017-05-02 |
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | Semperit Investments Asia Pte , Ltd. | KGO | Class I | 2017-05-02 |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | Revmedx, Inc. | PGZ | Class II | 2017-05-01 |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | Bovie Medical Corporation | GEI | Class II | 2017-05-01 |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider | Surgical Instrument Services and Savings, Inc. | NUJ | Class II | 2017-05-01 |
| K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval | C. R. Bard | FTL | Class II | 2017-05-01 |
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | OXE | Class II | 2017-04-28 |
| K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | OMP | Class II | 2017-04-28 |
| K163667 | RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) | Health Beacons, Inc. | PBY | Class II | 2017-04-28 |
| K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | NEU | Class II | 2017-04-27 |
| K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | GEX | Class II | 2017-04-27 |
| K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | OLP | Class II | 2017-04-25 |
| K170936 | Cutera enlighten III Laser System | Cutera, Inc. | GEX | Class II | 2017-04-25 |
| K163645 | DERMABOND PRINEO Skin Closure System | Ethicon, LLC | OMD | Class II | 2017-04-21 |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Covidien | GEI | Class II | 2017-04-21 |
| K170358 | joimax Endovapor 2 | Joimax GmbH | GEI | Class II | 2017-04-21 |
| K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil | Precision Surgical, LLC | GEI | Class II | 2017-04-21 |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | Halyard Health, Inc. | FYA | Class II | 2017-04-21 |
| K163415 | SlimShape System | Syneron Medical, Ltd. | GEI | Class II | 2017-04-20 |
| K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock | Patient Pocket, LLC | GEX | Class II | 2017-04-19 |
| K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2017-04-18 |
| K163523 | ECHELON CIRCULAR Powered Stapler | Ethicon Endo-Surgery, LLC | GDW | Class II | 2017-04-18 |
| K170533 | Model 330 Multifunction Aspirator | ZOLL Medical Corporation | BTA | Class II | 2017-04-18 |
| K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | PMC | Class II | 2017-04-17 |
| K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | OHS | Class II | 2017-04-14 |
| K170582 | Saf-T-Vac Smoke and Fluid Evacuator | Surgical Technology Laboratories, Inc. | GEI | Class II | 2017-04-14 |
| K170610 | PlasmaBlade T | Medtronic Advanced Energy | GEI | Class II | 2017-04-13 |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | C.R. Bard, Inc. | GDW | Class II | 2017-04-11 |
| K170724 | NeuroBlate System | Monteris Medical, | GEX | Class II | 2017-04-07 |
| K160549 | MEDICAL DIODE LASER SYSTEMS | Wuhan Gigaa Optronics Technology Co., Ltd. | GEX | Class II | 2017-04-07 |
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | GAW | Class II | 2017-04-06 |
| K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | 2017-04-06 |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | Medela AG | OMP | Class II | 2017-04-06 |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | Richard Wolf Medical Instruments Corporation | GEI | Class II | 2017-04-05 |
| K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | Airxpanders, Inc. | PQN | Class II | 2017-04-03 |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | Millennium Medical Technologies, Inc. | MUU | Class II | 2017-03-31 |
| K161257 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | GEX | Class II | 2017-03-31 |
| K170161 | New Deantronics E Green Electrosurgical Monopolar Pencils | New Deantronics Taiwan , Ltd. | GEI | Class II | 2017-03-29 |
| K162784 | Silk'n HST | Home Skinovations , Ltd. | OHS | Class II | 2017-03-25 |
| K162556 | LIGHTFUSION LED SYSTEM | Vitage Led, Ltd. | GEX | Class II | 2017-03-24 |
| K170329 | Basic, Dominant Flex | Modela AG | QPB | Class II | 2017-03-24 |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Clinical Laserthermia Systems, AB | GEX | Class II | 2017-03-23 |
| K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | OHT | Class II | 2017-03-23 |
| K170296 | CoreCath 2.7S | Medtronic Advanced Energy | GEI | Class II | 2017-03-20 |
| K163655 | Sparkling | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | GEX | Class II | 2017-03-17 |
| K170116 | Thermi Injectable RF Electrodes | Thermi | GEI | Class II | 2017-03-13 |
| K163152 | PROLENE Soft Polypropylene Mesh | ETHICON, Inc. | FTL | Class II | 2017-03-11 |
| K163118 | FLEX Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | 2017-03-09 |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | Bovie Medical Corporation | GEI | Class II | 2017-03-08 |
| K163450 | VIVA combo RF System | Starmed Co., Ltd. | GEI | Class II | 2017-03-08 |
| K170331 | Cyber Ho | Quanta System Spa | GEX | Class II | 2017-03-03 |
| K162947 | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler | Chongqing Qmi Surgical Co., Ltd. | GDW | Class II | 2017-03-03 |
| K163552 | iPulse SmoothSkin BARE Hair Removal Device | Cyden Limited | OHT | Class II | 2017-03-03 |
| K161892 | Slimming Treatment Device | Beijing Honkon Technologies Co., Ltd. | NUV | Class II | 2017-03-02 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | GAR | Class II | 2017-03-02 |
| K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler) | Covidien | GDW | Class II | 2017-03-02 |
| K161737 | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed | Myco Medical | NEW | Class II | 2017-03-02 |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | Lumenis, Ltd. | GEX | Class II | 2017-02-28 |
| K170105 | Jac-Cell Medic testers | Jac-Cell Medic | GEI | Class II | 2017-02-28 |
| K163191 | ComfortGuard Surgical Gown, i600, Film Reinforced | Gri Medical & Electrical Technology Co., Ltd. | FYA | Class II | 2017-02-27 |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | MUU | Class II | 2017-02-24 |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | Lifecell Corporation | FTM | Class II | 2017-02-24 |
| K162922 | GalaFORM 3D | Tepha, Inc. | OOD | Class II | 2017-02-23 |
| K161926 | ND YAG Q-switch Laser Therapy Machine | Beijing Adss Development Co., Ltd. | GEX | Class II | 2017-02-22 |
| K163651 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | GAT | Class II | 2017-02-17 |
| K170170 | Valleylab FT10 Electrosurgical Platform | Covidien, LLC | GEI | Class II | 2017-02-16 |
| K162570 | Miromatrix Biological Mesh TW | Miromatrix Medical, Inc. | FTM | Class II | 2017-02-16 |
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Tei Biosciences, Inc. | FTM | Class II | 2017-02-16 |
| K162365 | T-Cuff | Terumobct, Inc. | KCY | Class I | 2017-02-16 |
| K163548 | ENSEAL X1 Large Jaw Tissue Sealer | Ethicon Endo-Surgery, LLC | GEI | Class II | 2017-02-14 |
| K162608 | ClariFix Device | Arrinex, Inc. | GEH | Class II | 2017-02-14 |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | OXF | Class II | 2017-02-10 |
| K161629 | CRYLREX | Sm Eng Co., Ltd. | GAM | Class II | 2017-02-10 |
| K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | Tgs Medical Co., Ltd. | GDW | Class II | 2017-02-09 |
| K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | KGO | Class I | 2017-02-08 |
| K163173 | Handheld Diode Laser for Hair Removal | Liaoning Sidey Optoelectronics Technologies Co., Ltd. | OHT | Class II | 2017-02-08 |
| K161432 | MyNeWT Negative Pressure Wound Therapy System | Stortford Medical, LLC | OMP | Class II | 2017-02-08 |
| K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) | Curaseal, Inc. | FTM | Class II | 2017-02-03 |
| K163123 | Q-Switched Nd:YAG Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | GEX | Class II | 2017-02-02 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.