meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
2017-02-01

Clearances · page 36 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K162454 PicoWay Laser System Syneron Candela Corporation GEX Class II 2017-02-01
K161949 OsteoCool V-3 RF Ablation System Baylis Medical Company, Inc. GEI Class II 2017-01-31
K160471 Medline Non-Surgical Isolation Gown- Medline Industries, Inc. FYC Class II 2017-01-31
K162034 OBS Electrosurgical Generator (Model: OBS-350A) Baisheng Medical Co., Ltd. GEI Class II 2017-01-30
K162098 LED Phototherapy Device Li-Tek Electronic Technology Corporation OLP Class II 2017-01-30
K162790 V.A.C.ULTA Negative Pressure Wound Therapy System Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2017-01-26
K162851 eLyx-PRO Intelligent Sensory Concept SA GEX Class II 2017-01-24
K162802 Barrx Anorectal RFA Wand Covidien, LLC GEI Class II 2017-01-24
K161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs Wrp Asia Pacific Sdn. Bhd. KGO Class I 2017-01-23
K162932 Ranfac Fat Aspiration Cannula Ranfac, Corp. MUU Class II 2017-01-19
K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set Cardinalhealth OMP Class II 2017-01-19
K163541 Magseed Magnetic Marker System Endomagnetics Ltd., PBY Class II 2017-01-13
K162489 RED Light Device Zhongshan Bisen Plastic Electronic Products Co., Ltd. OHS Class II 2017-01-13
K163176 Exilis XP II BTL Industries, Inc. PBX Class II 2017-01-12
K162810 InSeca ARC Stylus, Aerin Console Aerin Medical, Inc. GEI Class II 2017-01-11
K162201 Desara TV, Desara Blue TV Caldera Medical, Inc. OTN Class II 2017-01-11
K162765 Venus Velocity Diode Laser System Venus Concept , Ltd. GEX Class II 2017-01-11
K163128 Epic Pro Biolase, Inc. GEX Class II 2017-01-11
K162490 Disc-FX System Elliquence, LLC GEI Class II 2017-01-06
K163142 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader ArthroCare Corporation GAT Class II 2017-01-06
K163454 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm Ethicon Endo-Surgery, LLC GDW Class II 2017-01-05
K160469 AGNES Gowoonsesang Cosmetics Co., Ltd. GEI Class II 2017-01-05
K161202 C2 Cryoballoon Ablation System C2 Therapeutics, Inc. GEH Class II 2017-01-05
K162770 Relign System Relign Corporation GEI Class II 2017-01-04
K163408 Isolator Multifunctional Linear Pen AtriCure, Inc. OCL Class II 2017-01-03
K163308 SMARTO Jeil Medical Corporation KIJ Class I 2016-12-27
K162193 XenMatrix AB Surgical Graft C. R. Bard PIJ Class II 2016-12-23
K161550 DynaMesh-VENTRAL Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft FTL Class II 2016-12-22
K162721 Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator Alliqua Biomedical, Inc. NRB Class II 2016-12-22
K162352 derma+flex QS High Viscosity Tissue Adhesive Chemence Medical, Inc. MPN Class II 2016-12-22
DEN150055 AeroForm Tissue Expander System Airxpanders, Inc. PQN Class II 2016-12-21
K162717 Evolution Esophageal Stent System – Partially Covered Cook Ireland, Ltd. ESW Class II 2016-12-21
K161307 NICO Myriad Nico Corporation GEI Class II 2016-12-21
K162421 IntelliCartTM System Dornoch Medical Systems JCX Class II 2016-12-21
K162461 Endoform Plastics and Reconstructive Matrix Aroa Biosurgery (Formerly Mesynthes Limited) FTM Class II 2016-12-20
DEN150022 Ultravision Visual Clearing System Alesi Surgical, Ltd. PQM Class II 2016-12-20
K160928 Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) Hartalega Sdb. Bhd. KGO Class I 2016-12-20
K160854 MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture Biomet Manafacturing Corp. GAT Class II 2016-12-19
K162578 Zerona Z6 OTC Erchonia Corporation OLI Class II 2016-12-16
DEN150038 CleanCisionTM Wound Retraction and Protection System Prescient Surgical PQI Class II 2016-12-16
K162371 Pulsaderm ACE-All Blue Nutra Luxe MD, LLC OLP Class II 2016-12-15
K162247 PERMATAPE Medos International SARL GAT Class II 2016-12-15
K162442 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 Gri Medical & Electrical Technology Co., Ltd. FYA Class II 2016-12-12
K163373 PK AIM Gyrus Acmi, Inc. GEI Class II 2016-12-12
K163190 InMode RF System Inmode MD , Ltd. GEI Class II 2016-12-12
K162114 Photon, Photon Plus Zolar Technology & Mfg Co., Inc. GEX Class II 2016-12-12
K160969 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler Shinemed, LLC GDW Class II 2016-12-12
K162512 truSculpt Cutera, Inc. PBX Class II 2016-12-09
K160487 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System Kci USA, Inc. OMP Class II 2016-12-09
K161632 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) Bios S.R.L. GEX Class II 2016-12-08
K163105 Emprint Ablation System Covidien, LLC NEY Class II 2016-12-06
K161757 Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads Victor Medical Instruments Co., Ltd. GDW Class II 2016-12-05
K163222 Discovery Pico Family Quanta System Spa GEX Class II 2016-12-05
K163098 Tri-Staple 2.0 Intelligent Cartridge Covidien, LLC GDW Class II 2016-12-05
K161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply Medela AG OMP Class II 2016-12-01
K150960 WoundPro Negative Pressure Wound Therapy System Pensar Medical, LLC OMP Class II 2016-12-01
K162676 Voyant Open Fusion Device Applied Medical Resources GEI Class II 2016-12-01
K161548 Osseointegrated Fixtures Southern Implants (Pty), Ltd. FZE Class II 2016-12-01
K163009 Litho Quanta System Spa GEX Class II 2016-12-01
K163106 CODMAN Integrated Bipolar Cord and Tubing Set Medos International SARL GEI Class II 2016-12-01
K163139 PleuraFlow System with FlowGlide Clearflow, Inc. OTK Class II 2016-11-30
K162450 ESPADA Acne-Clearing Blue Light Pen Foreo, Inc. OLP Class II 2016-11-30
K160705 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, Y. Jacobs Medical, Inc. NEW Class II 2016-11-23
K162396 SILK Surgical Suture Teleflexmedical, Inc. GAP Class II 2016-11-23
K162191 NAVILAS Laser System Od-Os GmbH GEX Class II 2016-11-22
K160761 DW-1C Dongwon Medical Co., Ltd. NEW Class II 2016-11-22
K163185 OptiLux LED Illuminator Isolux, LLC HBI Class II 2016-11-21
K162050 ZELTIQ CoolSculpting System Zeltiq Aesthetics, Inc. OOK Class II 2016-11-21
K162363 V30 system, V-Form Handpiece BC Medium applicator Viora , Ltd. GEX Class II 2016-11-18
K160564 TroClose1200 Gordian Surgical, Ltd. GAM Class II 2016-11-17
K161939 Avance Abdominal Dressing Kit Molnlycke Health Care Us, LLC OXJ Class II 2016-11-17
K162163 UltraShape System Syneron Medical, Ltd. OHV Class II 2016-11-17
K161905 Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd GDW Class II 2016-11-17
K162231 iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert Cyden Limited OHT Class II 2016-11-16
K161692 Diode Laser Therapy Machine Beijing Adss Development Co., Ltd. GEX Class II 2016-11-16
K162914 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. GEX Class II 2016-11-16
K153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Protect U Guard, LLC FXX Class II 2016-11-15
K162252 FasTouch Fixation System Via Surgical , Ltd. GDW Class II 2016-11-14
K162941 Ligasure Blunt Tip, Sealer/Divider, Nano-coated Covidien GEI Class II 2016-11-14
K162656 ESU-1 Electrosurgical Generator Tva Medical, Inc. GEI Class II 2016-11-10
K162310 XBraid TT Suture Tape Stryker GAT Class II 2016-11-10
K162781 Magma Spark Formatk Systems , Ltd. GEX Class II 2016-11-09
K161011 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive Adhezion Biomedical, LLC MPN Class II 2016-11-08
K161952 UltraShape System Syneron Medical, Ltd. OHV Class II 2016-11-07
K161638 SPEEDTRAP Graft Preparation System Medos International SARL GAT Class II 2016-11-07
K160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3) Primed Medical Products, Inc. FYC Class II 2016-11-04
K161935 Avance Foam Dressing Kit - XL Molnlycke Health Care Us, LLC OMP Class II 2016-11-04
K161636 Lipogems System Lipogems International Spa MUU Class II 2016-11-04
K161948 Avance Gauze Dressing Kits Molnlycke Health Care Us, LLC OMP Class II 2016-11-03
K161670 Lucid Q-PTP / HWA 55 Bison Medical Co, Ltd. GEX Class II 2016-11-02
K161378 joimax Electrosurgical Instruments Joimax GmbH GEI Class II 2016-11-02
K160141 miraDry System Miramar Labs, Inc. NEY Class II 2016-10-31
K160974 Gammex Cut-Resistant Glove Liner Ansell Healthcare Products, LLC KGO Class I 2016-10-28
K160488 Cutera enlighten III Laser System Cutera, Inc. GEX Class II 2016-10-28
K160312 FRAXIS DUO Ilooda Co,., Ltd. GEX Class II 2016-10-28
K162169 EdgeOne CO2 Laser Jeisys Medical, Inc. GEX Class II 2016-10-27
K162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps Medos International SARL GEI Class II 2016-10-26
K162762 NeuroBlate System Monteris Medical, Inc. GEX Class II 2016-10-26
K162695 truFreeze System CSA Medical, Inc. GEH Class II 2016-10-25
K162554 Gentrix Surgical Matrix Acell, Inc. FTM Class II 2016-10-21

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.