Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 37
- Latest Decision
- 2016-06-29
Clearances · page 38 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K152737 | Lite Touch | Focus Medical, LLC | GEX | Class II | 2016-06-29 |
| K160669 | ClariFix Device | Arrinex, Inc. | GEH | Class II | 2016-06-24 |
| K160602 | JustRight Surgical Vessel Sealing System | Justright Surgical | GEI | Class II | 2016-06-23 |
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | HAM | Class II | 2016-06-23 |
| K160691 | Acne Light Therapy Wand | Zuko, Inc. | OLP | Class II | 2016-06-21 |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | Bovie Medical Corporation | GEI | Class II | 2016-06-20 |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... | Kci USA, Inc. (Kinetic Concepts, Inc.) | OMP | Class II | 2016-06-20 |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL | Teleflexmedical, Inc. | GAT | Class II | 2016-06-16 |
| K153632 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | FTL | Class II | 2016-06-16 |
| K160821 | Tria Sapphire | Tria Beauty, Inc. | OLP | Class II | 2016-06-15 |
| K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | FXX | Class II | 2016-06-15 |
| K160539 | BiZact Open Sealer/Divider | Covidien | GEI | Class II | 2016-06-15 |
| DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2016-06-13 |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | OWW | Class II | 2016-06-10 |
| K152667 | ATOVEN-Reusable Laser Fiber | Diotech CO | GEX | Class II | 2016-06-09 |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | OXH | Class II | 2016-06-08 |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | PEM | Class II | 2016-06-07 |
| K152561 | Communicator Surgical Facemask with Clear Window | Prestige Ameritech , Ltd. | FXX | Class II | 2016-06-03 |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device | Ethicon, LLC | GAM | Class II | 2016-06-03 |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | PDZ | Class II | 2016-06-03 |
| K152856 | Helios III | Laseroptek Co., Ltd. | GEX | Class II | 2016-06-02 |
| K151229 | ABC D-FLEX PROBE | Conmed Corporation | GEI | Class II | 2016-06-02 |
| K160012 | O-pel Laser and families of probe delivery devices | Precise Light Surgical | GEX | Class II | 2016-06-02 |
| K153288 | Voyant Open Fusion Device | Applied Medical Resources | GEI | Class II | 2016-06-01 |
| K160900 | 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 | 2016-05-31 |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | M/s. Meril Endo Surgery Private Limited. | GAP | Class II | 2016-05-31 |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | FTM | Class II | 2016-05-26 |
| K160501 | Noxilizer Surgical Ruler | Noxilizer, Inc. | FTY | Class I | 2016-05-26 |
| K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | Sunfire Industries, Inc. | LEJ | Class II | 2016-05-20 |
| K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | Medtek Lighting Corp D/B/A Peacock Tanning | LEJ | Class II | 2016-05-19 |
| K160290 | Valleylab REM Polyhesive Infant Patient Return Electrode | Covidien, LLC | GEI | Class II | 2016-05-19 |
| K150553 | Filbloc | Assut Europe | NEW | Class II | 2016-05-19 |
| K160994 | C2 CryoBalloon Focal Pear Catheter | C2 Therapeutics, Inc. | GEH | Class II | 2016-05-19 |
| K152842 | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL | Boston Scientific Corporation | JCT | Class II | 2016-05-19 |
| K153663 | Vario 8/18/ci | Medela AG | BTA | Class II | 2016-05-18 |
| K160480 | PicoSure Workstation | Cynosure, Inc. | GEX | Class II | 2016-05-17 |
| K153236 | Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay | C.R. Bard, Inc. | FTL | Class II | 2016-05-13 |
| K152510 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | NEU | Class II | 2016-05-13 |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | Cardinal Health, Inc. | KGO | Class I | 2016-05-12 |
| K153670 | Genteel Lancing Device | Genteel, LLC | FMK | Class II | 2016-05-12 |
| K160053 | Monopolar single-use HF cable | Olympus Winter & Ibe GmbH | GEI | Class II | 2016-05-06 |
| K150364 | ERBE ESU Model VIO dV with Accessories | Erbe Elektromedizin GmbH | GEI | Class II | 2016-05-05 |
| K160952 | Alma Diode Tabletop Laser | Alma, Ltd. | GEX | Class II | 2016-05-05 |
| K161021 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | NEU | Class II | 2016-05-05 |
| K160639 | Electrosurgical Generator ESG-200 | Olympus Winter & Ibe GmbH | GEI | Class II | 2016-05-04 |
| K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | NEY | Class II | 2016-05-04 |
| K160050 | SERFAS 90-S Electrosurgical Probe | Stryker Corporation | GEI | Class II | 2016-05-03 |
| K153358 | Standard Clamp | Standard Bariatrics | GDJ | Class I | 2016-05-02 |
| K152336 | HEX tanning booth | J & B Products Ltd Dba Hex Tanning | LEJ | Class II | 2016-05-02 |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NUJ | Class II | 2016-05-02 |
| K152412 | T-32;T-40;T-44;T-52;T-72;TT-50 | Tanses Technologies, Inc. | LEJ | Class II | 2016-04-29 |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | Cook Biotech Incorporated | FTM | Class II | 2016-04-29 |
| K150598 | Blockade Surgical Gown | Medline Industries, Inc. | FYA | Class II | 2016-04-28 |
| K160128 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | GEI | Class II | 2016-04-28 |
| K160176 | Signia Stapler | Covidien | GDW | Class II | 2016-04-26 |
| K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | JCX | Class II | 2016-04-25 |
| K160227 | ACCENTO / HWA Dual/Single laser | Bison Medical Co, Ltd. | GEX | Class II | 2016-04-22 |
| K152059 | Disposable General Electrode | Modern Medical Equipment Manufacturing Limited | GEI | Class II | 2016-04-21 |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Terumo Cardiovascular Systems Corporation | GEI | Class II | 2016-04-21 |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | GEI | Class II | 2016-04-19 |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber | Surgical Laser Incorporated | GEX | Class II | 2016-04-15 |
| K160195 | Forma System, Forma Light System | Formatk Systems , Ltd. | ONF | Class II | 2016-04-15 |
| K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS | Pc Marketing, Inc. | LEJ | Class II | 2016-04-14 |
| K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | OHT | Class II | 2016-04-14 |
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | GAD | Class I | 2016-04-13 |
| K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | GEI | Class II | 2016-04-13 |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | C2 Therapeutics, Inc. | GEH | Class II | 2016-04-13 |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health, Inc. | FYA | Class II | 2016-04-13 |
| K153229 | Superbium | Bios S.R.L. | GEX | Class II | 2016-04-12 |
| K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM | Teleflexmedical, Inc. | GEI | Class II | 2016-04-08 |
| K153566 | Magma System | Formatk Systems , Ltd. | GEX | Class II | 2016-04-06 |
| K160368 | EVO platform | Quanta System Spa | GEX | Class II | 2016-04-05 |
| K160360 | Barrx FLEX RFA Energy Generator | Covidien, LLC | GEI | Class II | 2016-04-05 |
| K160160 | Non-Telescopic PenEvac | I.C Medical, Inc. | GEI | Class II | 2016-04-05 |
| K152428 | SensiCare PI Surgical Gloves | Medline Industries, Inc. | KGO | Class I | 2016-03-31 |
| K153564 | PURE CRYOGEN | Air Liquide Healthcare America Corporation | GEX | Class II | 2016-03-29 |
| K151943 | Vas-Q-Clip | Nanova Biomaterials, Inc. | FZP | Class II | 2016-03-25 |
| K160273 | truFreeze System | Csa Medial, Inc. | GEH | Class II | 2016-03-25 |
| K153202 | iMESH Tacker | Thd Lap | GDW | Class II | 2016-03-24 |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Cardinal Health 200, Inc. | KGO | Class I | 2016-03-24 |
| K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | OOK | Class II | 2016-03-23 |
| K152933 | Vesalius | Telea Electronic Engineering Srl | GEI | Class II | 2016-03-23 |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | Ethicon Endo-Surgery, LLC | GDW | Class II | 2016-03-22 |
| K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | GEH | Class II | 2016-03-22 |
| K153717 | Venus Versa System | Venus Concept , Ltd. | ONF | Class II | 2016-03-21 |
| K150915 | SPINAUT-P | Imedicom Co., Ltd. | GEI | Class II | 2016-03-18 |
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | FZP | Class II | 2016-03-18 |
| K160513 | Quanta System Surgical Laser fibers | Quanta System Spa | GEX | Class II | 2016-03-18 |
| K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | FTM | Class II | 2016-03-15 |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | GEX | Class II | 2016-03-15 |
| K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | GEX | Class II | 2016-03-09 |
| K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | KGO | Class I | 2016-03-09 |
| K152206 | SurgiPure XD Reconstructive Tissue Matrix | Tissue Regenix Group Plc | FTM | Class II | 2016-03-08 |
| K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | GEI | Class II | 2016-03-07 |
| K152238 | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5 | Sun Capsule, Inc. | LEJ | Class II | 2016-03-04 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | PEM | Class II | 2016-03-03 |
| K153746 | Dunamis Force DFX Tensile Tape | Dunamis, LLC | GAT | Class II | 2016-03-03 |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | PBY | Class II | 2016-03-02 |
| K153527 | PicoWay Laser System | Syneron Candela Corporation | GEX | Class II | 2016-03-02 |
| K151905 | 3400E series; E5400 series; E6400 series; Sundazzler series | Heartland Tanning, Inc. | LEJ | Class II | 2016-03-01 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.