Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 36
- Latest Decision
- 2020-08-05
Clearances · page 26 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200977 | Modular Toga | Operating Room Innovations, Inc. | FYA | Class II | 2020-08-05 |
| K193355 | Electrodes Handpieces for Mygen V-1000 RF System | RF Medical Co., Ltd. | GEI | Class II | 2020-08-03 |
| K201833 | BiPad Hand Activated, Disposable Bipolar Electrocautery Cords | Bipad Surgical, Inc. | GEI | Class II | 2020-07-31 |
| K191101 | Kendall NPWT Incision Management Dressing Kit | Cardinalhealth | OMP | Class II | 2020-07-31 |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | Cardinal Health200, LLC | FYA | Class II | 2020-07-29 |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC | GDW | Class II | 2020-07-27 |
| K193575 | Arthrex SutureTape | Arthrex, Inc. | GAT | Class II | 2020-07-24 |
| K201479 | DemeMASK | Demetech Corporation | FXX | Class II | 2020-07-24 |
| K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | GEI | Class II | 2020-07-24 |
| K201406 | Picowon | Wontech Co., Ltd. | GEX | Class II | 2020-07-22 |
| K201150 | InMode RF Multi-System | InMode , Ltd. | GEI | Class II | 2020-07-22 |
| K200818 | 3DMax MID Anatomical Mesh | C.R. Bard, Inc. | FTL | Class II | 2020-07-17 |
| K201672 | Signia Stapler (with new software) | Covidien | GDW | Class II | 2020-07-17 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | GEX | Class II | 2020-07-16 |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora , Ltd. | PBX | Class II | 2020-07-15 |
| K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2020-07-15 |
| K201018 | Encision AEM enTouch 2X Scissor | Encision, Inc. | GEI | Class II | 2020-07-15 |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | FTM | Class II | 2020-07-13 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | Galil Medical, Inc. | NEY | Class II | 2020-07-09 |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Kci USA, Inc. | OMP | Class II | 2020-07-08 |
| K200392 | REXSIN | Sm Eng Co., Ltd. | GAM | Class II | 2020-07-07 |
| K200947 | InMode System with the Morhpeus8 Applicators | InMode , Ltd. | GEI | Class II | 2020-07-02 |
| K192411 | Psoria-Shield AURORA | Psoria-Shield | FTC | Class II | 2020-07-02 |
| K201455 | Litho 150, Cyber Ho 150 | Quanta System Spa | GEX | Class II | 2020-06-30 |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | FST | Class II | 2020-06-30 |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | Ethicon Endo-Surgery, LLC | GDW | Class II | 2020-06-29 |
| K201164 | Venus Viva MD Device | Venus Concept USA, Inc. | GEI | Class II | 2020-06-26 |
| K200736 | Stardust Med | I.T.S. Group S.R.L. | GEX | Class II | 2020-06-26 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | Megadyne Medical Products, Inc. | FYD | Class II | 2020-06-26 |
| K193477 | Nd: YAG Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | GEX | Class II | 2020-06-24 |
| K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro) | Gtg Wellness Co., Ltd. | OHS | Class II | 2020-06-22 |
| K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Livsmed, Inc. | GEI | Class II | 2020-06-17 |
| K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde | Modern Medical Equipment Manufacturing, Ltd. | GEI | Class II | 2020-06-16 |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | FTM | Class II | 2020-06-15 |
| K200616 | E>EyeC | E-Swin | ONF | Class II | 2020-06-11 |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | QAU | Class II | 2020-06-10 |
| K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | 2020-06-09 |
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | GEI | Class II | 2020-06-09 |
| K200786 | Venus Epileve | Venus Concept USA, Inc. | GEX | Class II | 2020-06-09 |
| K201212 | Voyant Open Fusion Device | Applied Medical Resources Corp. | GEI | Class II | 2020-06-05 |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | OMD | Class II | 2020-06-05 |
| K200104 | Oxylight | Raja Trading Company, Inc. | GEX | Class II | 2020-06-04 |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | OCL | Class II | 2020-06-03 |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Hartalega Sdn Bhd | KGO | Class I | 2020-06-01 |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | GAR | Class II | 2020-05-29 |
| K200116 | PicoSecond Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2020-05-28 |
| K193665 | Frozen N | Yozma Bmtech Co., Ltd. | GEH | Class II | 2020-05-28 |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | MUU | Class II | 2020-05-28 |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | Ethicon Endo-Surgery | GEI | Class II | 2020-05-27 |
| K200525 | Medical Diode Laser Hair Removal System | Weifang Mingliang Electronics Co., Ltd. | GEX | Class II | 2020-05-27 |
| K201111 | GentleMax Pro Plus | Candela Corporation | GEX | Class II | 2020-05-26 |
| K200305 | NPseal | Guard Medical, Inc. | OKO | Class II | 2020-05-26 |
| K192560 | Surgical Gown | Shandong Kangli Medical Equipment Technology Co., Ltd. | FYA | Class II | 2020-05-22 |
| K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps | Adeor Medical AG | GEI | Class II | 2020-05-22 |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora , Ltd. | PBX | Class II | 2020-05-21 |
| K200751 | Photodynamic Therapy (PDT) Equipment | Shangdong Huamei Technology Co., Ltd. | GEX | Class II | 2020-05-21 |
| K192265 | gi-4000 Electrosurgical Generator | United States Endoscopy Group, Inc. | GEI | Class II | 2020-05-21 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | ESW | Class II | 2020-05-20 |
| K200390 | V.A.C. DERMATAC Drape | Kci USA, Inc. | OMP | Class II | 2020-05-18 |
| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | ONF | Class II | 2020-05-15 |
| K200169 | VFS1 Bipolar Electrosurgical Generator | FHC, Inc. | GEI | Class II | 2020-05-14 |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | QPB | Class II | 2020-05-14 |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | FTC | Class II | 2020-05-13 |
| K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | GEI | Class II | 2020-05-11 |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery, LLC | GEI | Class II | 2020-05-11 |
| K200501 | ArtiSential Laparoscopic Instrument-Electrodes | Livsmed, Inc. | GEI | Class II | 2020-05-11 |
| K200659 | Dermalux Tri-Wave MD | Aesthetic Technology, Ltd. | GEX | Class II | 2020-05-09 |
| K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | GEI | Class II | 2020-05-07 |
| K193189 | RFID Localization System | Health Beacons, Inc. | NEU | Class II | 2020-05-06 |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | OKO | Class II | 2020-05-04 |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | PQM | Class II | 2020-05-04 |
| K192295 | PDT-FACE | Beijing Adss Development Co., Ltd. | OLP | Class II | 2020-05-01 |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | FYA | Class II | 2020-04-30 |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | ONG | Class II | 2020-04-30 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | KKX | Class II | 2020-04-26 |
| K192856 | MT One | M&T S.R.L. | GEX | Class II | 2020-04-24 |
| K200847 | Surgical Face Mask | Mexpo International, Inc. | FXX | Class II | 2020-04-23 |
| K200167 | QuikClot Control+ | Z-Medica, LLC | POD | Class II | 2020-04-23 |
| K200168 | Dermapose Access | Puregraft, LLC | QPB | Class II | 2020-04-22 |
| K200185 | SYLFIRM X | VIOL Co., Ltd. | GEI | Class II | 2020-04-22 |
| K200559 | CarpX | Pavmed, Inc. | GEI | Class II | 2020-04-20 |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II | 2020-04-17 |
| K200118 | Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2020-04-17 |
| K193363 | Dermapose Refresh | Puregraft, LLC | MUU | Class II | 2020-04-14 |
| K200300 | VivAer Stylus | Aerin Medical, Inc. | GEI | Class II | 2020-04-13 |
| K193464 | ND:YAG Laser | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | 2020-04-13 |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | QAI | Class II | 2020-04-10 |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | Molnlycke Health Care Us, LLC | KGO | Class I | 2020-04-10 |
| K192138 | Rejuvapen NXT | Refine USA, LLC | QAI | Class II | 2020-04-09 |
| K200598 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | GEI | Class II | 2020-04-08 |
| K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | Medtronic, Inc. | FTL | Class II | 2020-04-08 |
| K191970 | Diode Laser Hair Removal System | Beijing Sano Laser S&T Development Co.,Ltd | GEX | Class II | 2020-04-06 |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | Medline Industries, Inc. | KGO | Class I | 2020-04-06 |
| K200576 | ClearMask Transparent Surgical Face Mask | Clearmask, LLC | FXX | Class II | 2020-04-06 |
| K192735 | Diode Laser Hair Removal Machine | Beijing Lead Beauty S & T Co., Ltd. | GEX | Class II | 2020-04-03 |
| K193591 | ARC 400 | Bowa-Electronics GmbH & Co. KG | GEI | Class II | 2020-04-02 |
| K191762 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2020-04-01 |
| K191065 | Venus VivaTM | Venus Concept USA, Inc. | GEI | Class II | 2020-04-01 |
| K192988 | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use | Medline Industries, Inc. | KGO | Class I | 2020-04-01 |
| K200455 | Trigger Switch and Cord | New Deantronics Taiwan , Ltd. | GEI | Class II | 2020-03-31 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.