Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 2019-07-26
Clearances · page 29 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | PEM | Class II | 2019-07-26 |
| K191733 | The ZIP Accessory Shuttle for PleuraFlow System | Clearflow, Inc. | OTK | Class II | 2019-07-26 |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | OCL | Class II | 2019-07-24 |
| K190678 | TempSure | Cynosure, Inc. | GEI | Class II | 2019-07-24 |
| K182407 | Exceed Microneedling device | Mt. Derm GmbH | QAI | Class II | 2019-07-19 |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | PKT | Class II | 2019-07-17 |
| K180992 | Biotex | Purgo Biologics, Inc. | NBY | Class II | 2019-07-16 |
| K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners | Davol Inc., Subsidiary of C.R. Bard | GDW | Class II | 2019-07-16 |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | GEX | Class II | 2019-07-12 |
| K191317 | StitchKit | Origami Surgical | NBY | Class II | 2019-07-12 |
| K191601 | Valleylab FT10 Electrosurgical Platform | Covidien | GEI | Class II | 2019-07-12 |
| K191138 | AeroForm Tissue Expander, Smooth | Airxpanders, Inc. | PQN | Class II | 2019-07-11 |
| K191252 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | MVR | Class II | 2019-07-09 |
| K191162 | EpiLaze Multi-wavelength Laser | Rohrer Aesthetics, LLC | GEX | Class II | 2019-07-09 |
| K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | NEY | Class II | 2019-07-08 |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) | Medline Industries, Inc. | FYA | Class II | 2019-07-04 |
| K191460 | PWD Platform Wound Dressing 3 x 5 Oblong | Applied Tissue Technologies, LLC | OMP | Class II | 2019-07-02 |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | Hartalega NGC Sdn. Bhd. | KGO | Class I | 2019-06-28 |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | GAM | Class II | 2019-06-27 |
| K190782 | FlexGard Cut-Resistant Glove Liners | Ldi Corporation | KGO | Class I | 2019-06-27 |
| K191166 | DigniCap Delta | Dignitana, Inc. | PMC | Class II | 2019-06-26 |
| K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2019-06-26 |
| K190743 | Venus Bliss | Venus Concept USA, Inc. | PBX | Class II | 2019-06-25 |
| K190052 | Radio Frequency Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | GEI | Class II | 2019-06-25 |
| K190443 | MMSphere | Galactic Beauty, LLC | OHS | Class II | 2019-06-24 |
| K183450 | EmBody System | Inmode MD , Ltd. | PBX | Class II | 2019-06-20 |
| K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | GEI | Class II | 2019-06-20 |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | PAY | Class II | 2019-06-19 |
| K183385 | NanoKnife System | Angiodynamics | OAB | Class II | 2019-06-18 |
| K182493 | Bovine Pericardial Tissue Patch | Tisgenx | FTM | Class II | 2019-06-18 |
| K190936 | Q-Switched Nd: YAG Laser System | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2019-06-17 |
| K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | GAW | Class II | 2019-06-14 |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | PEM | Class II | 2019-06-14 |
| K183566 | CLARITY II Laser System | Lutronic Corporation | GEX | Class II | 2019-06-14 |
| K183564 | Electrosurgical Generator | Fulwell, LLC | GEI | Class II | 2019-06-13 |
| K180511 | Eon FR | Dominion Aesthetic Technologies, Inc. | PKT | Class II | 2019-06-12 |
| K190422 | Viveve System 2.0 | Viveve Medical | GEI | Class II | 2019-06-12 |
| K191064 | Argon Handset | New Deantronics Taiwan , Ltd. | GEI | Class II | 2019-06-12 |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | OWT | Class II | 2019-06-12 |
| K191268 | Force Fiber Suture | Teleflex Medical Incorporated | GAT | Class II | 2019-06-11 |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max, Inc. | NEW | Class II | 2019-06-04 |
| K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | Pentax Medical, A Division of Pentax of America, Inc. | GEH | Class II | 2019-05-31 |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | OCL | Class II | 2019-05-30 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | ESW | Class II | 2019-05-29 |
| K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | FXX | Class II | 2019-05-27 |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | Molnlycke Health Care Us, LLC | KGO | Class I | 2019-05-24 |
| K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | GEX | Class II | 2019-05-24 |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | KGO | Class I | 2019-05-23 |
| K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. | OMP | Class II | 2019-05-23 |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | GEI | Class II | 2019-05-22 |
| K190823 | Erbe ESU Model VIO 3 with Accessories | Erbe Elektromedizin GmbH | GEI | Class II | 2019-05-22 |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | PDZ | Class II | 2019-05-15 |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | Jk-Holding GmbH | LEJ | Class II | 2019-05-10 |
| K190027 | SteriStay | Toul Meditech AB | ORC | Class II | 2019-05-10 |
| K183126 | Electrosurgical accessory | New Deantronics Taiwan , Ltd. | GEI | Class II | 2019-05-08 |
| K190643 | Medline Electrocautery Pencil | Medline Industries, Inc. | GEI | Class II | 2019-05-06 |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | MUU | Class II | 2019-05-03 |
| K183199 | TRIO Handpiece | Omniguide, Inc. | GEX | Class II | 2019-05-02 |
| K190551 | VASERlipo System | Solta Medical | QPB | Class II | 2019-05-01 |
| K190555 | PowerX Lipo System | Solta Medical | QPB | Class II | 2019-05-01 |
| K190817 | HS Fiber | Riverpoint Medical | GAT | Class II | 2019-05-01 |
| K190006 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2019-04-29 |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | QPC | Class II | 2019-04-26 |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | JCX | Class II | 2019-04-24 |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | Medline Industries, Inc. | FYA | Class II | 2019-04-24 |
| K183156 | V-Laser | Wontech Co., Ltd. | GEX | Class II | 2019-04-24 |
| K190407 | CryoLab | Cryoconcepts LP | GEH | Class II | 2019-04-22 |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. | QFC | Class II | 2019-04-19 |
| K183601 | CryoTouch | Cryoconcepts LP | GEH | Class II | 2019-04-18 |
| K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. | GDW | Class II | 2019-04-16 |
| K182924 | Diode Laser Treatment System | Weifang KM Electronics Co., Ltd. | GEX | Class II | 2019-04-15 |
| K183526 | Codman Electrosurgical Generator, Foot Pedal | Kls Martin GmbH + Co. KG | GEI | Class II | 2019-04-11 |
| K183398 | Endoform Restella | Aroa Biosurgery , Ltd. | FTM | Class II | 2019-04-11 |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH | LEJ | Class II | 2019-04-08 |
| K183445 | Erbe APCapplicators | Erbe Elektromedizin GmbH | GEI | Class II | 2019-04-04 |
| K190023 | BTL-084 | BTL Industries, Inc. | PBX | Class II | 2019-03-29 |
| K181505 | V.A.C. DERMATAC Drape | Kci USA, Inc. | OMP | Class II | 2019-03-28 |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | Pt. Medisafe Technologies | KGO | Class I | 2019-03-28 |
| K181929 | MiMo(TM) Negative Pressure Wound Therapy System | Baymax Research, Inc. | OMP | Class II | 2019-03-27 |
| K190392 | WaveLight FS200 Patient Interface | Alcon Laboratories, Inc. | GEX | Class II | 2019-03-26 |
| K183400 | EnVisio Navigation Sytem | Elucent Medical, Inc. | NEU | Class II | 2019-03-22 |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | KGO | Class I | 2019-03-22 |
| K181822 | RENASYS Touch; RENASYS Y-Connector | Smith & Nephew Medical Limited | OMP | Class II | 2019-03-21 |
| K183543 | ACTIV.A.C. Therapy Unit | Kci USA, Inc. | OMP | Class II | 2019-03-20 |
| K183260 | Sensilight Pro / Pistol IPL | El Global Trade, Ltd. | OHT | Class II | 2019-03-18 |
| K190354 | BRAUN Silk.expert Pro 5 | Cyden Limited | OHT | Class II | 2019-03-18 |
| K190366 | BRAUN Silk Expert Pro 3 | Cyden Limited | OHT | Class II | 2019-03-18 |
| K181633 | MTF Pre-Sutured Tendon | Musculoskeletal Transplant Foundation | GAT | Class II | 2019-03-15 |
| K183247 | dpl Faceware | Led Technologies, Inc. | OHS | Class II | 2019-03-14 |
| K190168 | Aquas Probes | Genicon, Inc. | GEI | Class II | 2019-03-14 |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) | Covidien | GDW | Class II | 2019-03-14 |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional | Synthes (USA) Products, LLC | FTM | Class II | 2019-03-13 |
| K181668 | FasTouch Absorbable Fixation System | Via Surgical , Ltd. | GDW | Class II | 2019-03-13 |
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | Bovie Medical Corporation | GEI | Class II | 2019-03-12 |
| K183180 | Caiman 5 Maryland | Aesculap, Inc. | GEI | Class II | 2019-03-12 |
| K182013 | EasyInstruments | Agency For Medical Innovations GmbH | GEI | Class II | 2019-03-11 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | MQR | Class II | 2019-03-07 |
| K182173 | Joule System | Sciton, Inc | GEX | Class II | 2019-03-06 |
| K190007 | Vydence Laser Family | Vydence Medical Industria E Comercio Ltda | GEX | Class II | 2019-03-01 |
| K182250 | Solero MTA Cart, 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 | 2019-02-28 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.