Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 31
- Latest Decision
- 2020-03-31
Clearances · page 27 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential | Semperit Technische Produkte Gesellchaft M.B.H. | KGO | Class I | 2020-03-31 |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Teleflex Medical | GAT | Class II | 2020-03-30 |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | 2020-03-30 |
| K193656 | SkyPulse | Fotona D.O.O. | GEX | Class II | 2020-03-27 |
| K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | FTL | Class II | 2020-03-27 |
| K200140 | Silhouette Instalift | Silhouette Lift, Inc. | GAM | Class II | 2020-03-27 |
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | Ellipse A/S | GEX | Class II | 2020-03-26 |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | OWT | Class II | 2020-03-26 |
| K193661 | LightWalker Laser System Family | Fotona D.O.O. | GEX | Class II | 2020-03-25 |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | NEW | Class II | 2020-03-25 |
| K193328 | IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. | ONF | Class II | 2020-03-25 |
| K200241 | TempSure System | Cynosure, LLC | PBX | Class II | 2020-03-25 |
| K193619 | Cry-Ac®, Cry-Ac-3®, Cry-Baby | Brymill Cryogenic Systems | GEH | Class II | 2020-03-25 |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Megadyne Medical Products, Inc. | GEI | Class II | 2020-03-24 |
| K193579 | PlasmaBlade X 3.0S LIGHT | Medtronic Navigation | GEI | Class II | 2020-03-24 |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | Stryker Corporation | FXY | Class II | 2020-03-21 |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | Cardinal Health200, LLC | FYA | Class II | 2020-03-20 |
| K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | GEX | Class II | 2020-03-20 |
| K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated | GEI | Class II | 2020-03-20 |
| K193530 | Deklene MAXX | Teleflex Medical | GAW | Class II | 2020-03-19 |
| K192272 | Wolf445nm | A.R.C Laser GmbH | GEX | Class II | 2020-03-17 |
| K200110 | SANDRO Dual | Wontech Co., Ltd. | GEX | Class II | 2020-03-16 |
| K193486 | Epic 980 | Biolase, Inc. | GEX | Class II | 2020-03-16 |
| K200522 | AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. | FYA | Class II | 2020-03-16 |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care Us, LLC | KGO | Class I | 2020-03-13 |
| K192720 | GIA Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2020-03-13 |
| K192483 | MeDioStar | Asclepion Laser Technologies GmbH | GEX | Class II | 2020-03-13 |
| K193367 | elysion-pro | High Technology Products S.L.U | GEX | Class II | 2020-03-12 |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | KGO | Class I | 2020-03-10 |
| K193446 | Bare: 808 | Luvo Medical Technologies, Inc. | GEX | Class II | 2020-03-10 |
| K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | 2020-03-10 |
| K183570 | LiquiBand Plus | Advanced Medical Solutions Limited | MPN | Class II | 2020-03-09 |
| K193426 | Elite iQ | Cynosure, LLC | GEX | Class II | 2020-03-09 |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | FTM | Class II | 2020-03-06 |
| K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | GEI | Class II | 2020-03-06 |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | Medline Industries, Inc. | KGO | Class I | 2020-03-06 |
| K192813 | Plasma IQ | Neauvia North America, Inc. | GEI | Class II | 2020-03-06 |
| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | ONF | Class II | 2020-03-05 |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | GEI | Class II | 2020-03-04 |
| K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | GEI | Class II | 2020-03-02 |
| K192637 | High Strength Suture | Yunyi (Beijing) Medical Device Co., Ltd. | GAT | Class II | 2020-03-02 |
| K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | KGO | Class I | 2020-02-28 |
| K200234 | Surgical laser fibers | Quanta System Spa | GEX | Class II | 2020-02-25 |
| K200184 | SmoothSkin Pure | Cyden Limited | OHT | Class II | 2020-02-21 |
| K192600 | Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 | Quanta System Spa | GEX | Class II | 2020-02-21 |
| K192617 | Gemini 810+980 Soft Tissue Laser | Azena Medical, LLC | GEX | Class II | 2020-02-20 |
| K192545 | Potenza | Jeisys Medical Incorporated | GEI | Class II | 2020-02-20 |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | GAQ | Class II | 2020-02-19 |
| K190909 | ArtiSential Bipolar Fenestrated Forceps | Livsmed, Inc. | GEI | Class II | 2020-02-13 |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC | NEY | Class II | 2020-02-13 |
| K191202 | CAPENERGY - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | PBX | Class II | 2020-02-11 |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | Sutter Medizintechnik GmbH | GEI | Class II | 2020-02-10 |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Caldera Medical, Inc. | PAH | Class II | 2020-02-07 |
| K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | FTC | Class II | 2020-02-06 |
| K183148 | OKLand Patient Return Electrode Pad | Auckland Medical Polymer(Tianjin) Co., Ltd. | GEI | Class II | 2020-02-04 |
| K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | GDW | Class II | 2020-01-23 |
| K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | OOK | Class II | 2020-01-21 |
| K192583 | PicoLazer Laser System | Rohrer Aesthetics, LLC | GEX | Class II | 2020-01-17 |
| K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | FYC | Class II | 2020-01-17 |
| K193611 | Viveve 2.0 System | Viveve Medical, Inc. | GEI | Class II | 2020-01-16 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | GEX | Class II | 2020-01-16 |
| K183284 | INTRAcel RF Microneedle System | Jeisys Medical, Inc. | GEI | Class II | 2020-01-15 |
| K190028 | UNO 30 | Genadyne Biotechnologies | OMP | Class II | 2020-01-15 |
| K193478 | XTRAC Momentum Excimer Laser System | Strata Skin Sciences, Inc. | GEX | Class II | 2020-01-14 |
| K192544 | Erchonia Emerald | Erchonia Corporation | OLI | Class II | 2020-01-13 |
| K192715 | CRF Radiofrequency Ablation System | Cambridge Interventional, LLC | GEI | Class II | 2020-01-07 |
| K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter | Erbe Elektromedizin GmbH | GEH | Class II | 2020-01-07 |
| K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | GEX | Class II | 2020-01-03 |
| K193375 | NeuroBlate System | Monteris Medical, | GEX | Class II | 2020-01-03 |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Careglove Global Sdn. Bhd. | KGO | Class I | 2019-12-30 |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD , Ltd. | GEI | Class II | 2019-12-27 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | Cook Biotech Incorporated | OXN | Class II | 2019-12-27 |
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | Datascope Corp. | GDW | Class II | 2019-12-26 |
| K193018 | Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. | GEI | Class II | 2019-12-20 |
| K191234 | APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets | Erbe Elektromedizin GmbH | GEI | Class II | 2019-12-20 |
| K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | ArthroCare Corporation | GEI | Class II | 2019-12-20 |
| K192471 | RHIN1 Stylus | Aerin Medical, Inc. | GEI | Class II | 2019-12-20 |
| K192755 | Soli-Lite LG4 Galileo | Silhouet-Tone Corporation | GEX | Class II | 2019-12-20 |
| K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Applied Medical Resources Corp. | GEI | Class II | 2019-12-20 |
| K192990 | Litho Evo | Quanta System Spa | GEX | Class II | 2019-12-20 |
| K192711 | Dannik Titanium Ligation Clip | Dannik | FZP | Class II | 2019-12-20 |
| K183213 | IceSense 3, ProSense, MultiSense | IceCure Medical , Ltd. | GEH | Class II | 2019-12-20 |
| K193004 | Monopolar Cord | New Deantronics Taiwan , Ltd. | GEI | Class II | 2019-12-19 |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | GAM | Class II | 2019-12-18 |
| K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | Fengh Medical Co., Ltd. | GDW | Class II | 2019-12-18 |
| K191898 | Sterile Latex Powder-Free Surgical Gloves | Modern Healthcare Corp. | KGO | Class I | 2019-12-18 |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Synovis Life Technologies, Inc. (Baxter International Inc.) | FTM | Class II | 2019-12-17 |
| K192539 | Deka Luxea | El.En Electronic Engineering Spa | GEX | Class II | 2019-12-16 |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | PSN | Class II | 2019-12-13 |
| K192569 | Diode Laser Therapy System | San HE Lefis Electronics Co., Ltd. | GEX | Class II | 2019-12-13 |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | OCL | Class II | 2019-12-13 |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | KPJ | Class II | 2019-12-13 |
| K192362 | Aero Blue Performance Surgical Gowns | O&M Halyard, Inc. | FYA | Class II | 2019-12-13 |
| K191086 | Exciplex | Clarteis | FTC | Class II | 2019-12-11 |
| K192516 | Diode Laser 808nm | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | 2019-12-10 |
| K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | ONF | Class II | 2019-12-06 |
| K192443 | Dextile Anatomical Mesh | Sofradim Production | FTL | Class II | 2019-12-06 |
| K191962 | Vitra 2 | Quantel Medical | GEX | Class II | 2019-12-05 |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2019-12-05 |
| K192224 | BTL-899 | Btl | GEI | Class II | 2019-12-05 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.