Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 40
- Latest Decision
- 2019-02-26
Clearances · page 30 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190356 | ClariFix | Arrinex, Inc. | GEH | Class II | 2019-02-26 |
| K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | OCL | Class II | 2019-02-25 |
| K183240 | Empower RF Catheter | Broncus Medical, Inc. | GEI | Class II | 2019-02-22 |
| K183693 | Doctor Tecar | Mectronic Medicale S.R.L. | PBX | Class II | 2019-02-22 |
| K190105 | ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. | JCX | Class II | 2019-02-21 |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J | New Deantronics Taiwan , Ltd. | GEI | Class II | 2019-02-19 |
| K183217 | IPL Hair Removal Device | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | OHT | Class II | 2019-02-15 |
| K181507 | PREVENA RESTOR(TM) Incision Management System | Kci USA, Inc. | OMP | Class II | 2019-02-15 |
| K190075 | Aurora Evacuator | Rebound Therapeutics | GEI | Class II | 2019-02-12 |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use | Ezisurg Medical Co., Ltd. | GDW | Class II | 2019-02-11 |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | FYD | Class II | 2019-02-07 |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | OTN | Class II | 2019-02-07 |
| K183118 | dpl SpotLite | Led Technologies, Inc. | OLP | Class II | 2019-02-07 |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | FTM | Class II | 2019-02-07 |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | Ethicon Endo-Surgery, LLC | GDW | Class II | 2019-02-06 |
| K182191 | Invia Abdominal Dressing Kit | Medela AG | OMP | Class II | 2019-02-01 |
| K182094 | Family of Venus RF Systems - Heal | Venus Concept USA, Inc. | PBX | Class II | 2019-02-01 |
| K183452 | Vbeam Prima Laser System | Candela Corp. | GEX | Class II | 2019-02-01 |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use | Ezisurg Medical Co., Ltd. | GDW | Class II | 2019-02-01 |
| K181893 | T-PLUS | Wintecare SA | PBX | Class II | 2019-01-29 |
| K183004 | WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. | GAM | Class II | 2019-01-28 |
| K183001 | WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. | GAM | Class II | 2019-01-28 |
| K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | FXX | Class II | 2019-01-24 |
| K183346 | FLOW 90 Wand | ArthroCare Corporation | GEI | Class II | 2019-01-24 |
| K183671 | LG PRA.L DERMA LED MASK | Lg Electronics.Inc | OHS | Class II | 2019-01-22 |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | OMP | Class II | 2019-01-18 |
| K183538 | VIVA combo RF System | Starmed Co., Ltd. | GEI | Class II | 2019-01-17 |
| K173847 | Disposable Ultra Reinforced Surgical Gown | Xiantao Rayxin Medical Products Co., Ltd. | FYA | Class II | 2019-01-16 |
| K181071 | SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. | GEI | Class II | 2019-01-16 |
| K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | GEI | Class II | 2019-01-15 |
| K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | OOK | Class II | 2019-01-14 |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | FTC | Class II | 2019-01-11 |
| K182409 | Applied Tissue Technologies PWD Platform Wound Dressing | Applied Tissue Technologies, LLC | OMP | Class II | 2019-01-11 |
| K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | I-Tech Industries Srl | NUV | Class II | 2019-01-11 |
| K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices | ETHICON, Inc. | NEW | Class II | 2019-01-10 |
| K181204 | RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited | OMP | Class II | 2019-01-10 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | MQR | Class II | 2019-01-10 |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. | KGO | Class I | 2019-01-09 |
| K183392 | PicoLO Nd:YAG Picosecond Laser System | Laseroptek Co., Ltd. | GEX | Class II | 2019-01-04 |
| K182741 | SculpSure | Cynosure | PKT | Class II | 2019-01-03 |
| K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | OUK | Class II | 2019-01-03 |
| K182045 | Lotus III Multi-Pulsed Er: Yag Laser System | Laseroptek Co., Ltd. | GEX | Class II | 2018-12-27 |
| K173747 | REXLENE | Sm Eng Co., Ltd. | GAW | Class II | 2018-12-21 |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | OCL | Class II | 2018-12-19 |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | BTA | Class II | 2018-12-19 |
| K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | GEI | Class II | 2018-12-14 |
| K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. | FTL | Class II | 2018-12-14 |
| K180359 | BTL-FR2000 | BTL Industries, Inc. | GEI | Class II | 2018-12-13 |
| K182997 | enlighten III Laser System | Cutera, Inc. | GEX | Class II | 2018-12-12 |
| K182812 | Medline Cautery Electrode (SILICONE) | Medline Industries, Inc. | GEI | Class II | 2018-12-12 |
| K180999 | Mygen V-1000 RF System | RF Medical Co., Ltd. | GEI | Class II | 2018-12-11 |
| K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | Formatk Systems , Ltd. | GEX | Class II | 2018-12-11 |
| K182831 | SabreLine and SabreGuard Laser Fibers | Coloplast Corp. | GEX | Class II | 2018-12-10 |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation | GEI | Class II | 2018-12-10 |
| K180175 | SignalMark Lung Biopsy Site Marker | View Point Medical, Inc. | GDW | Class II | 2018-12-07 |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | OCL | Class II | 2018-12-04 |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery , Ltd. | FTL | Class II | 2018-12-04 |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | ONG | Class II | 2018-11-30 |
| K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | Finemec Co., Ltd. | GEX | Class II | 2018-11-30 |
| K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | 2018-11-30 |
| K182587 | Device Electrosurgical Generator ESG-150 | Olympus Winter & Ibe GmbH | GEI | Class II | 2018-11-29 |
| K181667 | Thoraguard System | Centese, Inc. | BTA | Class II | 2018-11-29 |
| K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | 2018-11-28 |
| K182169 | AdVance XP Male Sling | Boston Scientific Corporation | OTM | Class II | 2018-11-27 |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | Integra LifeSciences Corporation | GEI | Class II | 2018-11-27 |
| K183009 | HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES | Hemostatix Medical Technologies, LLC | GEI | Class II | 2018-11-26 |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | Covidien | GEI | Class II | 2018-11-19 |
| K180650 | Amsel Endo Occluder | Amsel Medical Corporation | FZP | Class II | 2018-11-15 |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | Aziyo Biologics, Inc. | FTM | Class II | 2018-11-15 |
| K182604 | New Era | Step UP Skin Laser, LLC | GEX | Class II | 2018-11-14 |
| K172602 | Miracu | Feeltech Co., Ltd. | NEW | Class II | 2018-11-14 |
| K182653 | Voyant Maryland Fusion Device | Applied Medical Resources Corp. | GEI | Class II | 2018-11-14 |
| K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Covidien, LLC | GEI | Class II | 2018-11-06 |
| K182270 | Cellene CO2 Laser System | Bio-Med USA, Inc. | GEX | Class II | 2018-11-02 |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics | QDG | Class II | 2018-11-02 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | MQR | Class II | 2018-11-02 |
| K180415 | Invia White Foam NPWT | Medela AG | OMP | Class II | 2018-11-02 |
| DEN170056 | Parathyroid Detection (Model PTeye) System | Aibiomed, Corp. | QDF | Class II | 2018-11-02 |
| K182087 | DynaMesh-POSTERIOR | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | FTL | Class II | 2018-10-31 |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NUJ | Class II | 2018-10-31 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | GEX | Class II | 2018-10-31 |
| K182082 | Tumark for Eviva, Tumark for Brevera | Somatex Medical Technologies GmbH | NEU | Class II | 2018-10-31 |
| K182392 | Frozen C | B.M. Tech. Worldwide Co., Ltd. | GEH | Class II | 2018-10-30 |
| K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | Ethicon Endo-Surgery, LLC | FZP | Class II | 2018-10-30 |
| K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | FTC | Class II | 2018-10-29 |
| K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | NEY | Class II | 2018-10-24 |
| K182365 | TempSure System | Cynosure, Inc. | GEI | Class II | 2018-10-24 |
| K180205 | AVELLE Negative Pressure Wound Therapy System | Convatec Limited | OMP | Class II | 2018-10-19 |
| K181941 | Swift System | Emblation , Ltd. | NEY | Class II | 2018-10-18 |
| K182669 | Youlaser CO2 | Quanta System Spa | GEX | Class II | 2018-10-17 |
| K182036 | NeuroBlate System | Monteris Medical, | GEX | Class II | 2018-10-15 |
| K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | GEI | Class II | 2018-10-12 |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH | LEJ | Class II | 2018-10-11 |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corporation | NBY | Class II | 2018-10-11 |
| K182244 | Voyant Electrosurgical Generator | Applied Medical Resources Corp. | GEI | Class II | 2018-10-11 |
| K180872 | SCARLET SRF | VIOL Co., Ltd. | GEI | Class II | 2018-10-11 |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture | Teleflex Medical Incorporated | GAT | Class II | 2018-10-10 |
| K181868 | SHINY RPL System | Ids, Ltd. | ONF | Class II | 2018-10-05 |
| K181867 | Deka Smartxide2 Trio | El.En Electronic Engineering Spa | GEX | Class II | 2018-10-02 |
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | ETHICON, Inc. | GAM | Class II | 2018-09-28 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.