meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
39
Latest Decision
2016-10-21

Clearances · page 37 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K161481 Ambient HipVac 50 Wand with Integrated Finger Switches ArthroCare Corporation GEI Class II 2016-10-21
K160181 COLORADO THERAPEUTICS XENOGRAFT IMPLANT Colorado Therapeutics, LLC FTM Class II 2016-10-20
K161941 Pulsaderm Acne Device Nutra Luxe MD, LLC OLP Class II 2016-10-19
K161797 Avance Tubing, Avance Y-Connector, Avance ViewPad Molnlycke Health Care Us, LLC OMP Class II 2016-10-19
K160706 ReNew V Handpiece Laparoscopic Instruments Microline Surgical, Inc. GEI Class II 2016-10-19
K161981 Olive Plus Ama Network, Inc. GEX Class II 2016-10-14
K161410 VT·One, VT·One 60days Carilex Medical, Inc. OMP Class II 2016-10-13
K160103 Spetzler Malis Dual Illuminating Bipolar Forceps Synergetics GEI Class II 2016-10-12
K162599 IcePearl 2.1 CX L, IceForce 2.1 CX L Galil Medical , Ltd. GEH Class II 2016-10-11
K161038 PK Morcellator Gyrus Acmi, Inc. GEI Class II 2016-10-07
K160100 Prestige Ameritech Pediatric/Child’s Face mask Prestige Ameritech OXZ Class II 2016-10-07
K162547 Viveve System Viveve, Inc. GEI Class II 2016-10-06
K161925 CO2 Laser Therapy Machine Beijing Adss Development Co., Ltd. GEX Class II 2016-10-05
K161885 The Cellfina System Ulthera, Inc. OUP Class II 2016-10-05
K161480 R2 Dermal Cooling System R2 Dermatology GEH Class II 2016-10-05
K161050 ACTABOND Topical Skin Adhesive Bergen Medical Products, Inc. MPN Class II 2016-10-04
K161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2016-10-04
K161458 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care Indiba USA, Inc. PBX Class II 2016-10-03
K162416 IRIDEX Cyclo G6 Laser System, G-Probe Illuminate Iridex Corporation GEX Class II 2016-09-29
K162126 Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthroCare Corporation GEI Class II 2016-09-29
K161424 Phasix Mesh C.R. Bard, Inc. OOD Class II 2016-09-29
K152163 RENASYS GO Smith & Nephew, Inc. OMP Class II 2016-09-29
K161002 Aprima Smartesis Centesis Pump Cook Incorporated BTA Class II 2016-09-28
K161825 PK AIM Gyrus Acmi, Inc. GEI Class II 2016-09-26
K161185 LUCERNA Dental Laser Viax Dental Lab GEX Class II 2016-09-26
K160880 Photonica Professional Ward Photonics, LLC OLI Class II 2016-09-23
K161994 Aerin Medical Stylus Aerin Medical, Inc. GEI Class II 2016-09-22
K160413 Sterling 5W Diode Laser CAO Group, Inc. GEX Class II 2016-09-21
K161086 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Sterilmed, Inc. NUJ Class II 2016-09-20
K161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra Ellipse A/S GEX Class II 2016-09-16
K161804 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider Covidien GEI Class II 2016-09-16
K151962 KBL Sunlamp Products (= Device Bundling name) Kbl AG LEJ Class II 2016-09-15
K161294 Compound W Wart Removal System Dual Power Medtech Products, Inc. GEH Class II 2016-09-15
K160529 Pledgeted COR-SUTURE QUICK LOAD Lsi Soultions GAW Class II 2016-09-15
K162053 PhotonBlade Invuity, Inc. GEI Class II 2016-09-15
K162047 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated Covidien GEI Class II 2016-09-15
K161551 TR-100 BTL Industries, Inc. PBX Class II 2016-09-13
K161043 Profound System Syneron Candela Corporation PBX Class II 2016-09-12
K161356 Matrix LS-40 CO2 Laser System Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd GEX Class II 2016-09-09
K160754 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) Venclose, Inc. GEI Class II 2016-09-09
K160554 Enseal X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC GEI Class II 2016-09-09
K161581 Arthrex Synergy RF System Arthrex, Inc. GEI Class II 2016-09-09
K161758 Weck Auto Endo10 Automatic Endoscopic Clip Applier Teleflex Medical FZP Class II 2016-09-07
K161600 Resection Electrodes Olympus Winter & Ibe GmbH JOS Class II 2016-09-06
K160269 Surgical Face Masks (Ear loops and Tie-on) San-M Package Co., Ltd. FXX Class II 2016-09-06
K161565 DUO Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd ONF Class II 2016-09-01
K152405 IBL 5000 Tanning Booth Ibl Acquisitions, LLC LEJ Class II 2016-09-01
K162129 RENASYS-G Gauze Dressing Kits with Soft Port Smith & Nephew, Inc. OMP Class II 2016-08-31
K161570 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large Lc Medical Concepts, Inc. OMP Class II 2016-08-29
K152197 Skypro, SP01 Mask Skypro Medical Supplies Company FXX Class II 2016-08-26
K161503 ORION Yerim Engineering Co., Ltd. GEX Class II 2016-08-26
K161092 GalaSHAPE 3D Tepha, Inc. OOD Class II 2016-08-23
K161615 Accurett H&O Equipments, Nv/Sa GEH Class II 2016-08-23
K162074 Werewolf RF20000 Controller, FLOW 50 Wand ArthroCare Corporation GEI Class II 2016-08-22
K160329 InMode System MiniFX Handpiece Inmode MD , Ltd. PBX Class II 2016-08-19
K153364 Kerecis SecureMesh Kerecis Limited OXE Class II 2016-08-19
K160366 Electrosurgical disposable grounding pads Top-Rank Health Care Co., Ltd. ODR Class II 2016-08-19
K161403 A.R.C. Laser Surgical Fibers and Probes A.R.C Laser GmbH GEX Class II 2016-08-16
K161661 Thermi RF Accessories Thermi GEI Class II 2016-08-12
K160331 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp Covidien GEI Class II 2016-08-12
K153089 'cottony' II TAPE, PLEDGETS Teleflexmedical, Inc. GAT Class II 2016-08-12
K162075 NICO TRIOwand Nico Corporation GEI Class II 2016-08-11
K161286 IPL Therapy Machine Beijing Adss Development Co., Ltd. ONF Class II 2016-08-04
K153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply Smith & Nephew Medical, Ltd. OMP Class II 2016-08-04
K161199 EndyMed Contour Handpiece Endymed Medical, Ltd. PBX Class II 2016-08-01
K161507 Cianna Medical SAVI Scout Reflector and SAVI Scout System Cianna Medical, Inc. PDW Class II 2016-07-29
K161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating Bovie Medical Corporation GEI Class II 2016-07-29
K161849 Bright Tanda Beauty Canada, Inc. OHS Class II 2016-07-29
K161771 Medilas H Laser Fibers Dornier Medtech America, Inc. GEX Class II 2016-07-28
K160339 Cardinal Health Isolation Gown Cardinal Health200, LLC FYC Class II 2016-07-28
K161020 XSTAT-12, 3-Pack, XSTAT-12, 1-Pack Revmedx, Inc. PGZ Class II 2016-07-28
K161008 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE Hartalega Sdn Bhd KGO Class I 2016-07-28
K161669 Waterlase Express Biolase, Inc. GEX Class II 2016-07-28
K153124 DuraLazeTM HoLEP Laser Fiber Medkey, LLC GEX Class II 2016-07-26
K161722 VITRUVIAN ULTIMATE ASPIRATOR Black & Black Surgical, Inc. QPB Class II 2016-07-26
K161557 truFreeze System CSA Medical, Inc. GEH Class II 2016-07-26
K153727 INTRAcel Premium Fractional RF Micro Needle (FRM) System Jeisys Medical, Inc. GEI Class II 2016-07-21
K160470 SculpSure Cynosure, Inc. PKT Class II 2016-07-21
K161137 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload Cardica, Inc. GDW Class II 2016-07-20
K160333 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider Surgical Instrument Service and Savings, Inc. NUJ Class II 2016-07-20
K153498 Operio Toul Meditech AB ORC Class II 2016-07-20
K161052 OsteoFab Patient Specific Facial Device Oxford Performance Materials, Inc. KKY Class II 2016-07-20
K152731 XP1100 RF BTL Industries, Inc. GEI Class II 2016-07-20
K160271 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 San-M Package Co., Ltd. MSH Class II 2016-07-15
K160988 Biopor, AOC Porous Polyethylene, Cerepor Ceremed , Inc. KKY Class II 2016-07-14
K153087 IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved Ivy Sports Medicine, LLC GAT Class II 2016-07-14
K160744 LOOK PTFE Suture Surgical Specialties Corporation NBY Class II 2016-07-13
K161337 CryoDose H or Similar Nuance Medical, LLC GEH Class II 2016-07-12
K153568 InMode Plus System Inmode MD , Ltd. PBX Class II 2016-07-12
K161726 E-Pack Procedure Kit ETHICON, Inc. GAM Class II 2016-07-12
K160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Cardinal Health, Inc. KGO Class I 2016-07-11
K153055 ACE Electrosurgical Resection and Vaporization Electrodes Series Ace Medical Devices Pvt. , Ltd. GEI Class II 2016-07-11
K152703 PlasmaBlade TnA Tonsil and Adenoid Dissection Device Medtronic Advanced Energy GEI Class II 2016-07-08
K161089 sensiLight Mini El Global Trade, Ltd. OHT Class II 2016-07-08
K160896 ULTRASHAPE POWER SYSTEM Syneron Medical, Ltd. OHV Class II 2016-07-08
K161305 Habib EUS RFA Emcision , Ltd. GEI Class II 2016-07-07
K161296 Cool Renewal Cool Renewal, LLC GEH Class II 2016-07-06
K153017 Voyant Fine Fusion Applied Medical Resources GEI Class II 2016-07-06
K160607 PicoWay Laser System Syneron Candela Corporation GEX Class II 2016-07-05
K153749 3 Series Phototherapy Unit Daavlin Distributing Company FTC Class II 2016-06-30

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