Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 35
- Latest Decision
- 2016-02-29
Clearances · page 39 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack | Kci USA, Inc. | OMP | Class II | 2016-02-29 |
| K152082 | Vesocclude Polymer Ligating Clip | Vesocclude Medical, LLC | FZP | Class II | 2016-02-26 |
| K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | GEI | Class II | 2016-02-26 |
| K160392 | Novilase Laser Therapy System, Model LTS-2 | Novian Health, Inc. | GEX | Class II | 2016-02-26 |
| K152736 | SKIN CARE | C.I.S, Ltd. | GEX | Class II | 2016-02-25 |
| K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | OHS | Class II | 2016-02-25 |
| K153677 | The Cellfina System | Ulthera, Inc. | OUP | Class II | 2016-02-25 |
| K152141 | High Pressure Tanning Lamps | Blv Licht-Und Vakuumtechnik GmbH | LEJ | Class II | 2016-02-25 |
| K151337 | Strialite | Centre Light Solutions, LLC | OHS | Class II | 2016-02-24 |
| K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources | GEI | Class II | 2016-02-19 |
| K151793 | InMode RF System | Inmode MD , Ltd. | GEI | Class II | 2016-02-19 |
| K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | OMP | Class II | 2016-02-19 |
| K152611 | V20 system | Viora , Ltd. | GEX | Class II | 2016-02-19 |
| K152702 | ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) | Ent Biotech Solutions | GEI | Class II | 2016-02-18 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | GAR | Class II | 2016-02-17 |
| K153081 | Clear Bi-Light | Michael Todd, LP | OLP | Class II | 2016-02-15 |
| K153718 | Spirit Hair Removal laser Family | Active Optical Systems , Ltd. | GEX | Class II | 2016-02-12 |
| K153307 | HS SutureTape | Riverpoint Medical | GAT | Class II | 2016-02-12 |
| K151569 | Tranberg CLS Laser Fiber | Clinical Laserthermia Systems, AB | GEX | Class II | 2016-02-12 |
| K152476 | Exofin High Viscosity Tissue Adhesive | Chemence Medical Products, Inc. | MPN | Class II | 2016-02-09 |
| K152898 | DIODE LASER THERAPY SYSTEMS | Beijing Sincoheren Science and Tech. Development Co., Ltd. | GEX | Class II | 2016-02-09 |
| K152868 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | GAT | Class II | 2016-02-08 |
| K153489 | Cryocare CS Surgical System | Healthtronics | GEH | Class II | 2016-02-05 |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | FWP | Class II | 2016-02-05 |
| K152529 | NaturaLase CO2 Laser System | Focus Medical, LLC | GEX | Class II | 2016-02-04 |
| K153459 | TACVAC | Athena Gtx | BTA | Class II | 2016-01-28 |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | OMP | Class II | 2016-01-28 |
| K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Sportarredo Group S.C. | LEJ | Class II | 2016-01-27 |
| K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | AtriCure, Inc. | FZP | Class II | 2016-01-27 |
| K152741 | Mepiseal Soft Silicone Sealant | Molnlycke Health Care Us, LLC | OMP | Class II | 2016-01-22 |
| K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | GEI | Class II | 2016-01-22 |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | FWP | Class II | 2016-01-20 |
| K153681 | PleuraFlow System | Clearflow, Inc. | OTK | Class II | 2016-01-20 |
| K152790 | Venus Versa System | Venus Concept , Ltd. | ONF | Class II | 2016-01-20 |
| K143713 | Lustre PRO Light System | Ambicare Health, Ltd. | GEX | Class II | 2016-01-19 |
| K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | GEI | Class II | 2016-01-15 |
| K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm | Emerson & Co. Srl | KGO | Class I | 2016-01-15 |
| K152134 | Reprocessed Vessel Sealer | Sterilmed, Inc. | NUJ | Class II | 2016-01-15 |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge | Cardica, Inc. | GDW | Class II | 2016-01-15 |
| K153675 | Paragon T2 Wand with Integrated Cable | ArthroCare Corporation | GEI | Class II | 2016-01-15 |
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | OUH | Class II | 2016-01-15 |
| K150032 | GluStitch Twist Tissue Adhesive | Glustitch, Inc. | MPN | Class II | 2016-01-14 |
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | NTB | Class II | 2016-01-13 |
| K151083 | BioBridge Collagen Matrix | Fibralign Corporation | OWY | Class II | 2016-01-08 |
| K153541 | Coldplay CryoBalloon® Ablation System | C2 Therapeutics, Inc. | GEH | Class II | 2016-01-07 |
| K152313 | Medline ReNewal Reprocessed Endopath Endoscopic Instruments | Surgical Instrument Services and Savings, Inc. | NUJ | Class II | 2016-01-06 |
| K151104 | OTELO LL | Spineart | GAD | Class I | 2016-01-06 |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | New Deantronics Taiwan , Ltd. | GEI | Class II | 2016-01-05 |
| K143004 | VENTURI MiNO TG600/14 | Talley Group, Ltd. | OMP | Class II | 2016-01-05 |
| K150459 | FloSure Ventilation Patch | Simex Medizintechnik GmbH | OMP | Class II | 2016-01-05 |
| K151273 | InMode FRF Applicator | Inmode MD , Ltd. | GEI | Class II | 2016-01-04 |
| K152889 | SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS | Biorenew Labs, LLC | OLP | Class II | 2015-12-30 |
| K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | NEU | Class II | 2015-12-30 |
| K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | Conmed Corporation | GEI | Class II | 2015-12-29 |
| K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | ONT | Class II | 2015-12-29 |
| K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | GEX | Class II | 2015-12-23 |
| K150664 | NeoLas | Sheaumann Laser, Inc. | GEX | Class II | 2015-12-22 |
| K141157 | BONDEASE TOPICAL SKIN ADHESIVE | Optmed, Inc. | MPN | Class II | 2015-12-22 |
| K150997 | RUBY STAR | Bison Medical Co, Ltd. | GEX | Class II | 2015-12-22 |
| K152714 | Quanta Forte | Quanta System Spa | GEX | Class II | 2015-12-21 |
| K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension | Conmed Corporation | GEI | Class II | 2015-12-18 |
| DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | PAY | Class II | 2015-12-18 |
| K152636 | Laser Dock | Patient Pocket, LLC | GEX | Class II | 2015-12-17 |
| K152219 | PK AIM | Gyrus Acmi, Inc. | GEI | Class II | 2015-12-17 |
| K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | LEJ | Class II | 2015-12-17 |
| K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | NEU | Class II | 2015-12-17 |
| K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein | St. Marys Rubbers Pvt, Ltd. | KGO | Class I | 2015-12-11 |
| K152153 | MicroSpot Handpiece | Asclepion Laser Technologies GmbH | GEX | Class II | 2015-12-11 |
| K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | 2015-12-11 |
| K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | FTM | Class II | 2015-12-09 |
| DEN150010 | Dignitana AB DigniCap System | Dignitana AB | PMC | Class II | 2015-12-08 |
| K152012 | EVO platform | Quanta System Spa | GEX | Class II | 2015-12-08 |
| K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser , Ltd. | GEX | Class II | 2015-12-08 |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | Revmedx, Inc. | PGZ | Class II | 2015-12-07 |
| K152436 | Suntanning Lamps | Interlectric Corporation | LEJ | Class II | 2015-12-07 |
| K152417 | Adler MicroMed Laser Surgery Fibers | Adler Micromed, Inc. | GEX | Class II | 2015-12-01 |
| K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | Medline Industries, Inc. | KGO | Class I | 2015-11-27 |
| K152490 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | OMD | Class II | 2015-11-25 |
| K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | GEX | Class II | 2015-11-25 |
| K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | GAT | Class II | 2015-11-25 |
| K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | GEI | Class II | 2015-11-24 |
| K151710 | SNaP Wound Care System | Spiracur, Inc. | OKO | Class II | 2015-11-19 |
| K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | GEI | Class II | 2015-11-19 |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | PBX | Class II | 2015-11-19 |
| K152678 | TYRX Neuro Antibacterial Envelope | Tyrx, Inc. | FTL | Class II | 2015-11-17 |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | KGO | Class I | 2015-11-16 |
| K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free) | Anhui Anyu Latex Products Co., Ltd. | KGO | Class I | 2015-11-16 |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | Lucenxia Prescience AG | KGO | Class I | 2015-11-16 |
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | GCB | Class I | 2015-11-12 |
| K152618 | PANTHER Cutter Stapler | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | GDW | Class II | 2015-11-12 |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing | Kci USA, Inc. | OMP | Class II | 2015-11-06 |
| K152203 | UTERMOHLEN CRYO PROFESSIONAL | Koninklijke (Royal) Utermohlen | GEH | Class II | 2015-11-06 |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | Taiwan Surgical Corporation | FZP | Class II | 2015-11-06 |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | Resorba Medical GmbH | GAM | Class II | 2015-11-02 |
| K151872 | Avance Y-Connector S | Molnlycke Health Care Us, LLC | OMP | Class II | 2015-11-02 |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | Pt. Medisafe Technologies | KGO | Class I | 2015-11-02 |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | GEI | Class II | 2015-11-02 |
| K142410 | Elliquence Electrodes | Elliquence, LLC | GEI | Class II | 2015-10-30 |
| K151109 | Lumenis Smart532 Laser System | Lumenis, Inc. | GEX | Class II | 2015-10-30 |
| K152273 | Cosmedico Ultraviolet Lamps of Various Models | Cosmedico Light, Inc. | LEJ | Class II | 2015-10-30 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.