Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 40
- Latest Decision
- 2015-06-18
Clearances · page 41 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K143003 | iPulse Smooth Skin Gold Hair Removal System | Ipulse Limited | OHT | Class II | 2015-06-18 |
| K150089 | NanoKnife System | AngioDynamics, Inc. | OAB | Class II | 2015-06-18 |
| K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | FZP | Class II | 2015-06-17 |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Acell, Inc. | FTM | Class II | 2015-06-17 |
| K150920 | truFreeze System | CSA Medical, Inc. | GEH | Class II | 2015-06-17 |
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | HCF | Class I | 2015-06-16 |
| K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | GEI | Class II | 2015-06-16 |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters | Medela AG | OMP | Class II | 2015-06-12 |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | GDW | Class II | 2015-06-11 |
| K143559 | XP1000 RF | BTL Industries, Inc. | GEI | Class II | 2015-06-11 |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc | Devon Medical Products | OMP | Class II | 2015-06-09 |
| K150140 | MCL 31 Dermablate | Asclepion Laser Technologies GmbH | GEX | Class II | 2015-06-05 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | OWT | Class II | 2015-06-05 |
| K142833 | INTRAGen | Jeisys Medical, Inc. | OUH | Class II | 2015-06-04 |
| K150042 | PleuraFlow System | Clearflow, Inc. | OTK | Class II | 2015-06-02 |
| K150778 | Various Brands of Ultraviolet Lamps | Cosmedico Light, Inc. | LEJ | Class II | 2015-05-29 |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | Covidien, LLC | GDW | Class II | 2015-05-29 |
| K150824 | TD-Wand | Tdm Surgitech, Inc. | GEI | Class II | 2015-05-28 |
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | ONF | Class II | 2015-05-27 |
| K150091 | Versatex Monofilament Mesh | Sofradim Production | FTL | Class II | 2015-05-26 |
| K140386 | LUMINA 24 | Rogers Sciences, Inc. | GEX | Class II | 2015-05-26 |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | MUU | Class II | 2015-05-22 |
| K151222 | Cautery Tip Cleaner | Key Surgical, Inc. | GEI | Class II | 2015-05-22 |
| K142385 | Whisper Pump System | Wound RX Medical, LLC | OMP | Class II | 2015-05-22 |
| K150151 | SmartGownTM surgical gown | Cardinal Health 200, Inc. | FYA | Class II | 2015-05-21 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Advanced Energy | GEI | Class II | 2015-05-21 |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | OLI | Class II | 2015-05-21 |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | Ethicon Endo-Surgery, LLC | GDW | Class II | 2015-05-18 |
| K150230 | SculpSure | Cynosure, Inc. | PKT | Class II | 2015-05-15 |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | OXH | Class II | 2015-05-12 |
| K150161 | Venus Viva SR Device | Venus Concept , Ltd. | GEI | Class II | 2015-05-12 |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | PDZ | Class II | 2015-05-08 |
| K142192 | Insightra Freedom Ventral Hernia Repair System | Insightra Medical | FTL | Class II | 2015-05-07 |
| K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte, Ltd. | FXX | Class II | 2015-05-05 |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA, Inc. | GEH | Class II | 2015-05-04 |
| K150035 | V10 system | Viora , Ltd. | PBX | Class II | 2015-05-01 |
| K142469 | 2D Mercy TAPE & 3D Mercy TAPE | Children'S Mercy Hospital | PIR | Class I | 2015-05-01 |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | Genadyne Biotechnologies, Inc. | OMP | Class II | 2015-04-30 |
| K142073 | ST'RIM | Thiebaud Sas | MUU | Class II | 2015-04-29 |
| K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters | Smith & Nephew, Inc. | OMP | Class II | 2015-04-29 |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | OLI | Class II | 2015-04-24 |
| K142061 | SILHOUETTE INSTALIFT | Silhouette Lift, Inc. | GAM | Class II | 2015-04-24 |
| K143666 | Noblex Long Pulse Alexandrite Laser | Finemec Co., Ltd. | GEX | Class II | 2015-04-23 |
| K150993 | NICO TRIOwand | Nico Corporation | GEI | Class II | 2015-04-23 |
| K150134 | Basic, Dominant Flex, KV-6 | Medela AG | QPB | Class II | 2015-04-21 |
| K142216 | Tranberg CLS Thermal Therapy System | Clinical Laserthermia Systems, AB | GEX | Class II | 2015-04-21 |
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | Cardinalhealth | OMP | Class II | 2015-04-20 |
| K150212 | DeScribe Transparent PFD Patch | On Light Sciences, Inc. | PKO | Class II | 2015-04-20 |
| K142186 | DIODE LASER HAIR REMOVAL SYSTEM | Shenzhen Gsd Tech Co., Ltd. | GEX | Class II | 2015-04-17 |
| K150326 | PicoWay Laser System | Candela Corporation | GEX | Class II | 2015-04-16 |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Ceremed , Inc. | KKY | Class II | 2015-04-16 |
| K143536 | Voyant Fine Fusion Device | Applied Medical Resources | GEI | Class II | 2015-04-16 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | KKX | Class II | 2015-04-14 |
| K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | GEI | Class II | 2015-04-13 |
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS | El.En Electronic Engineering Spa | GEX | Class II | 2015-04-13 |
| K133697 | BREAST-MED TISSUE MARKER | Breast-Med, Inc. | NEU | Class II | 2015-04-10 |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | Katalyst Surgical, LLC | HBI | Class II | 2015-04-09 |
| K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | OHS | Class II | 2015-04-09 |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | GEX | Class II | 2015-04-09 |
| K150051 | Exilite | BTL Industries, Inc. | ONF | Class II | 2015-04-08 |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | OTO | Class II | 2015-04-06 |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | OTO | Class II | 2015-04-06 |
| K150027 | CYMA | Whitecap Technologies, LLC | GEX | Class II | 2015-04-03 |
| K143654 | Valleylab LS10 Generator | Covidien, LLC | GEI | Class II | 2015-04-03 |
| K143475 | VAPR Tripolar Suction Electrode | Depuy Mitek | GEI | Class II | 2015-04-03 |
| K143043 | Tanning Lamp | Unilam Co., Ltd. | LEJ | Class II | 2015-04-02 |
| K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | GAT | Class II | 2015-04-02 |
| K141181 | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES | Led Technologies, LLC | OHS | Class II | 2015-03-31 |
| K142818 | Phasix Mesh | C. R. Bard | OOD | Class II | 2015-03-31 |
| K141785 | MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES | Bsd Medical Corp. | NEY | Class II | 2015-03-31 |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | OXC | Class II | 2015-03-30 |
| K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | FXX | Class II | 2015-03-27 |
| K150291 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | FTL | Class II | 2015-03-27 |
| K143517 | Voyant Open Sealer-Divider Device | Applied Medical Resources | GEI | Class II | 2015-03-27 |
| K141961 | GENADYNE SPIRO FOAM DRESSING KIT | Genadyne Biotechnologies, Inc. | OMP | Class II | 2015-03-26 |
| K141847 | AVANCE FOAM DRESSING KITS | Molnlycke Health Care Us, LLC | OMP | Class II | 2015-03-26 |
| K142822 | PLIASURE Polyglycolide Synthetic Absorbable Suture | ETHICON, Inc. | GAM | Class II | 2015-03-26 |
| K142706 | Modified ONFLEX Mesh | C.R. Bard, Inc. | FTL | Class II | 2015-03-25 |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health, Inc. | FXX | Class II | 2015-03-24 |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | FWP | Class II | 2015-03-23 |
| K140477 | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES | Molnlycke Health Care Us, LLC | KGO | Class I | 2015-03-23 |
| K142711 | ONFLEX Mesh | C.R. Bard, Inc. | FTL | Class II | 2015-03-20 |
| K133788 | COOK HOLMIUM LASER FIBER | Cook Incorporated | GEX | Class II | 2015-03-18 |
| K142992 | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) | Shanghai Jinxiang Latex Products Co., Ltd. | KGO | Class I | 2015-03-18 |
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | Sofradim Production | FTL | Class II | 2015-03-13 |
| K141237 | HARMONY LITE | Alma, Inc. | ONF | Class II | 2015-03-13 |
| K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | GEI | Class II | 2015-03-12 |
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners | C.R. Bard, Inc. | GDW | Class II | 2015-03-12 |
| K143598 | Lapro-Clip Auto Suture Reusable Long Clip Applier | Covidien, LLC | FZP | Class II | 2015-03-12 |
| K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | GEX | Class II | 2015-03-10 |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners | C.R. Bard, Inc. | GDW | Class II | 2015-03-09 |
| K141790 | AQANIFE | Ovesco Endoscopy AG | GEI | Class II | 2015-03-06 |
| K143109 | XP300 | BTL Industries, Inc. | GEI | Class II | 2015-03-06 |
| K141467 | SURGICAL GOWN | Xuchang Zhengde Environstar Medical Products Co.,L | FYA | Class II | 2015-03-05 |
| K141975 | WATERLASE IPLUS S | Biolase, Inc. | GEX | Class II | 2015-03-05 |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | GEH | Class II | 2015-03-05 |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | FXX | Class II | 2015-03-04 |
| K142916 | SVED Wound Treatment System | Cardinalhealth | OMP | Class II | 2015-03-04 |
| K143301 | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit | Integrated Healing Technologies | OMP | Class II | 2015-03-03 |
| K142956 | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit | Integrated Healing Technologies | OMP | Class II | 2015-02-24 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.