Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 32
- Latest Decision
- 2008-10-16
Clearances · page 59 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | Crosstex International | FXX | Class II | 2008-10-16 |
| K082232 | EVIS MD PLANTIUM BLUE | Ageless Beauty Corporation | GEX | Class II | 2008-10-15 |
| K082666 | ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | GEI | Class II | 2008-10-15 |
| K082890 | VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 | Vnus Medical Technologies, Inc. | GEI | Class II | 2008-10-15 |
| K082445 | CURATIVE980 DIODE LASER | Oroscience, Inc. | GEX | Class II | 2008-10-15 |
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | GAQ | Class II | 2008-10-14 |
| K080275 | NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Iasis Medical, Inc. | OMP | Class II | 2008-10-09 |
| K082096 | POWERLIPO LASER SYSTEM | Lutronic Corporation | GEX | Class II | 2008-10-08 |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | Barrx Medical, Incorporated | GEI | Class II | 2008-10-08 |
| K082311 | EXSUDEX WOUND DRAINAGE PUMP | The Medical Company | OMP | Class II | 2008-10-08 |
| K082247 | EVIS MD PLATINUM RED LIGHT THERAPY | Ageless Beauty Corporation | GEX | Class II | 2008-10-08 |
| K081010 | BARD 3DMAX MESH | Davol Inc., Sub. C. R. Bard, Inc. | FTL | Class II | 2008-10-07 |
| K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR | Bovie Medical | GEI | Class II | 2008-10-02 |
| K073000 | LUMAPROBE | Clareblend, Inc. | GEX | Class II | 2008-10-01 |
| K073022 | CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 | Clareblend, Inc. | GEX | Class II | 2008-10-01 |
| K081777 | VENTRIO HERNIA PATCH | C.R. Bard, Inc. | FTL | Class II | 2008-09-29 |
| K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | National Advanced Endoscopy Devices, Inc. | GEI | Class II | 2008-09-29 |
| K082004 | SMOOTHKIT+ | Osyris | GEX | Class II | 2008-09-26 |
| K081503 | AED MONOPOLAR LAP ACCESSORIES | National Advanced Endoscopy Devices, Inc. | GEI | Class II | 2008-09-25 |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | ESW | Class II | 2008-09-25 |
| K080382 | SELLAS | Dinona Co., Ltd. | GEX | Class II | 2008-09-24 |
| K073498 | LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM | Rudolf Medical GmbH + Co. KG | GEI | Class II | 2008-09-19 |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | American Medical Systems, Inc. | OTN | Class II | 2008-09-17 |
| K080638 | CLARO | Clrs Technology Corporation | GEX | Class II | 2008-09-17 |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | PSN | Class II | 2008-09-17 |
| K073572 | MATRIX RF APPLICATOR | Syneron Medical, Ltd. | GEX | Class II | 2008-09-17 |
| K082279 | EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 | St Jude Medical | OCL | Class II | 2008-09-16 |
| K080216 | SUPRAMESH EXTRA | S. Jackson, Inc. | FTL | Class II | 2008-09-15 |
| K082484 | ACCELAWAVE SYSTEM | Genesis Biosystems, Inc. | ONF | Class II | 2008-09-12 |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Lumenis, Inc. | GEX | Class II | 2008-09-11 |
| K081644 | BEAMER ARGON PROBE | Conmed Corporation | GEI | Class II | 2008-09-10 |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | Optimedica Corporation | GEX | Class II | 2008-09-09 |
| K082426 | RENASYS EZ | Smith & Nephew, Inc. | OMP | Class II | 2008-09-05 |
| K082216 | TBD ETHICON MESH | ETHICON, Inc. | FTL | Class II | 2008-09-05 |
| K081225 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM | Cardica, Inc. | FZP | Class II | 2008-09-05 |
| K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | Boston Scientific Corporation | ESW | Class II | 2008-09-05 |
| K080412 | ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | GAM | Class II | 2008-09-04 |
| K073317 | STARLIGHT, MODEL PD9012 | F.P. Rubinstein Y Cia S.R.L. | GEX | Class II | 2008-09-03 |
| K081042 | MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES | Bsd Medical Systems Corp. | NEY | Class II | 2008-09-03 |
| K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | Kimberly-Clark Corp. | FYA | Class II | 2008-09-03 |
| K081652 | CLAROS NANO DENTAL LASER SYSTEM | Elexxion AG | GEX | Class II | 2008-08-28 |
| K081559 | GENESIS | Medisiss | GEI | Class II | 2008-08-28 |
| K071023 | REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C | Reach Surgical, Inc. | GDW | Class II | 2008-08-28 |
| K082323 | ARTHROCARE ARTHROWANDS | Arthrocare Corp. | GEI | Class II | 2008-08-28 |
| K081275 | BOSTON SCIENTIFIC SURGICAL MESH | Boston Scientific Corp | PAH | Class II | 2008-08-27 |
| K073158 | SCULPTURE 2.94 ER:YAG SYSTEM | Hoya Conbio, Inc. | GEX | Class II | 2008-08-27 |
| K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | Molnlycke Health Care Us, LLC | KGO | Class I | 2008-08-26 |
| K082197 | RHYTEC, INC., PORTRAIT PSR | Rhytec Incorporated | GEI | Class II | 2008-08-22 |
| K073427 | MEDILAS D FAMILY LASERS | Dornier Medtech America, Inc. | GEX | Class II | 2008-08-20 |
| K073579 | DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | FTL | Class II | 2008-08-18 |
| K072974 | SURGIMESH XB | Aspide Medical | FTL | Class II | 2008-08-18 |
| K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE | Cutera, Inc. | GEX | Class II | 2008-08-15 |
| K081126 | PARIETEX COMPOSITE MONO PM MESH | Sofradim Production | FTL | Class II | 2008-08-13 |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | Ventlab Corp. | ODR | Class II | 2008-08-13 |
| K082025 | BODY-JET | Human Med AG | QPB | Class II | 2008-08-13 |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | Omniguide, Inc. | GEX | Class II | 2008-08-12 |
| K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | Xodus Medical, Inc. | GEI | Class II | 2008-08-12 |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | Primed Medical Products, Inc. | FXX | Class II | 2008-08-11 |
| K082028 | LASERPEEL SOFT-MET MODIFIED ERBIUM LASER | Global USA Distribution, LLC | GEX | Class II | 2008-08-08 |
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | MDM | Class I | 2008-08-08 |
| K081476 | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE | Surgical Concept Designs | KKX | Class II | 2008-08-08 |
| K081457 | ATRILAZE LASER ABLATION SYSTEM | Medical Cv, Inc. | GEX | Class II | 2008-08-08 |
| K081766 | PKS OMNI INSTRUMENT | Gyrus-Acmi L.P. | GEI | Class II | 2008-08-08 |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | Iridex Corp | GEX | Class II | 2008-08-07 |
| K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 | Gyrus Acmi, Inc. | GEI | Class II | 2008-08-06 |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | KPJ | Class II | 2008-08-06 |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | Senorx, Inc. | NEU | Class II | 2008-08-01 |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | Brennen Medical, LLC | FTM | Class II | 2008-07-31 |
| K082033 | NANNOLIGHT INTENSE PULSED LIGHT SYSTEM | Global USA Distribution, LLC | GEX | Class II | 2008-07-31 |
| K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE | Gyrus Acmi, Inc. | GEI | Class II | 2008-07-31 |
| K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | FTA | Class II | 2008-07-30 |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | Genadyne Biotechnologies, Inc. | BTA | Class II | 2008-07-30 |
| K071759 | LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) | Live Tissue Connect, Inc. | GEI | Class II | 2008-07-30 |
| K081678 | CONMED BEAMER SYSTEM C600 | Kls Martin GmbH + Co. KG | GEI | Class II | 2008-07-29 |
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL | Surgrx, Inc. | GEI | Class II | 2008-07-28 |
| K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V | Power Medical Interventions, Inc. | GDW | Class II | 2008-07-25 |
| K080292 | EPICOR ABLATION SYSTEM | St Jude Medical | OCL | Class II | 2008-07-25 |
| K080357 | MEDELA INVIA WOUND THERAPY | Medela AG | OMP | Class II | 2008-07-24 |
| K081431 | MEG LAPAROSCOPIC ELECTRODES | Bovie Medical | GEI | Class II | 2008-07-24 |
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | Surgicraft , Ltd. | FTL | Class II | 2008-07-24 |
| K080463 | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES | Alma Lasers , Ltd. | GEX | Class II | 2008-07-23 |
| K073616 | FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE | Electromedics Co. , Ltd. | GEI | Class II | 2008-07-23 |
| K081593 | POWER ASPIRATOR, MODEL LS2 OR LS2DP | Medical Device Resource Corp. | QPB | Class II | 2008-07-23 |
| K073246 | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | NAE | Class I | 2008-07-23 |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Medela AG | BTA | Class II | 2008-07-23 |
| K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 | Peak Surgical, Inc. | GEI | Class II | 2008-07-22 |
| K080341 | ENDODRAPE(TM) | Vortek Surgical, LLC | KKX | Class II | 2008-07-21 |
| K072334 | SIALO DRAIN | Sialo Technology, Ltd. | OAJ | Class I | 2008-07-18 |
| K081619 | CHROMOLITE EP | Chromogenex Technologies Limited | GEX | Class II | 2008-07-18 |
| K080731 | PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE | Osyris | GEX | Class II | 2008-07-17 |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | GAR | Class II | 2008-07-15 |
| K080975 | FENCER 308 EXCIMER LASER SYSTEM | Kera Harvest/Laser Max Medical Technologies Corp | GEX | Class II | 2008-07-15 |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | NWJ | Class II | 2008-07-15 |
| K080897 | VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Talley Medical | OMP | Class II | 2008-07-15 |
| K081882 | MODIFICATION TO XYLOS SURGICAL MESH | Xylos Corporation | FTM | Class II | 2008-07-11 |
| K081039 | LIPO CANNULA | Millennium Medical Technologies, Inc. | QPB | Class II | 2008-07-10 |
| K073074 | KEY LASER III 1243 US WITH DETECT | Kavo America | GEX | Class II | 2008-07-10 |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | NTB | Class II | 2008-07-09 |
| K081015 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Biolitec, Inc. | GEX | Class II | 2008-07-08 |
| K080496 | MOSAIC ECO2 LASER SYSTEM | Lutronic Corporation | GEX | Class II | 2008-07-07 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.