meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
37
Latest Decision
2011-10-20

Clearances · page 51 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112626 LIPSONIX(R) SYSTEM MODEL 2 Medicis Technologies Corporation OHV Class II 2011-10-20
K111402 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL Kimberly-Clark FXX Class II 2011-10-20
K110912 SMART TOUCH UVTHERAPY MULTIPLE MACHINE Daavlin Distributing Co. FTC Class II 2011-10-20
K112874 EZ VEIN INFLATABLE TOURNIQUET Dominion Medical Devices, LLC KCY Class I 2011-10-17
K111436 PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX Brennen Medical, LLC FTM Class II 2011-10-14
K110687 RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) Acclarent, Inc. KAM Class I 2011-10-07
K111784 VENUS SWAN SYSTEM Venus Concept , Ltd. GEI Class II 2011-10-07
K111859 ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK Galil Medical, Inc. GEH Class II 2011-10-07
K111343 CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS Crosstex International, Inc. FXX Class II 2011-10-06
K112715 CANDELA GENTLEMAX FAMILY OF LASERS Candela Corp. GEX Class II 2011-10-05
K110672 ETWO SKIN TREATMENT SYSTEM Syneron, Ltd. GEI Class II 2011-10-03
K112442 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM Biolitec Medical Devices, Inc. GEX Class II 2011-09-30
K111412 SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK Steerable Technologix GEI Class II 2011-09-30
K112609 DESARA MESH Caldera Medical, Inc. OTN Class II 2011-09-30
K112131 NEODYNE DRESSING Neodyne Biosciences, Inc. MDA Class I 2011-09-29
K111350 MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM Medicam, Inc. ONF Class II 2011-09-29
K112136 TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE Kunshan Jiehong Nonwoven Product Co., Ltd. KKX Class II 2011-09-29
K111878 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES Cardinal Health, Inc. KGO Class I 2011-09-29
K111475 AURIGA XL Starmedtec GmbH GEX Class II 2011-09-28
K110462 KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE Kepler Medtec GEI Class II 2011-09-26
K111946 TEPHAFLEX MESH Tepha, Inc. OOD Class II 2011-09-26
K103150 KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK Kimberly-Clark OXZ Class II 2011-09-23
K110913 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY Endoscopic Technologies, Inc. D/B/A Estech OCL Class II 2011-09-23
K111733 CORELEADER SCAR-DIMMER Coreleader Biotech Co., Ltd. MDA Class I 2011-09-22
K111069 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT Osteosymbionics, LLC MNF Class II 2011-09-22
K111868 STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING Cardinal Health-Medical Products and Services KGO Class I 2011-09-21
K112253 CERALAS 147NM DIODE LASER SYSTEM Biolitec, Inc. GEX Class II 2011-09-20
K112257 BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE Molnlycke Health Care Us, LLC KGO Class I 2011-09-20
K102359 PICASSO/ PICASSO LITE/ PICASSO PERIO Amd Lasers, LLC GEX Class II 2011-09-16
K111559 SURGICAL MASKS Shanghai Neo-Medical Import & Export Co., Ltd. FXX Class II 2011-09-16
K110370 Q-CLEAR Light Age, Inc. PDZ Class II 2011-09-15
K111360 SHEAUMANN PL-980 Sheaumann Lasers GEX Class II 2011-09-14
K111359 SHEAUMANN PL-1064 Sheaumann Lasers GEX Class II 2011-09-13
K112031 ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION Alma Lasers, Inc. GEX Class II 2011-09-13
K112400 SMARTSHEARS Nuscience Consulting and Management Group, LLC FZT Class I 2011-09-12
K111285 AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING Salient Surgical Technologies, Inc. GEI Class II 2011-09-09
K110754 CRYOPEN CRYOSURGICAL SYSTEM, K102214 Cryopen, Inc. GEH Class II 2011-09-09
K111887 CLOSUREFAST RADIOFREQUENCY CATHETER Covidien GEI Class II 2011-09-09
K112324 CERALAS 980NM DIODE LASER FAMILY Biolitec Medical Devices, Inc. GEX Class II 2011-09-06
K111139 DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U Ansell Healthcare Products, Inc. KGO Class I 2011-09-02
K112421 EMG SUCTION UNIT Emg Technology Co., Ltd. JCX Class II 2011-09-01
K112341 SNAP WOUND CARE SYSTEM Spiracur, Inc. OKO Class II 2011-08-29
K111172 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES Daavlin Distributing Co. FTC Class II 2011-08-29
K111535 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER Exact Medical Manufacturing, Inc. FYA Class II 2011-08-26
K111584 XYLOS MACRO-POROUS SURGICAL MESH Xylos Corporation FTM Class II 2011-08-25
K111592 YOULASER CO2 LASER SYSTEM Quanta System Spa GEX Class II 2011-08-25
K112089 BIOGEL ORTHOPOR BROWN SURGICAL GLOVE Molnlycke Health Care Us, LLC KGO Class I 2011-08-24
K110301 SILK'N FX Home Skinovations , Ltd. OHS Class II 2011-08-19
K100874 LIPOSONIX SYSTEM, MODEL 1 P00XXXX Medicis Technologies Corporation OHV Class II 2011-08-19
K111807 MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... Medline Industries, Inc. KGO Class I 2011-08-18
K111881 VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT Coloplast A/S OTM Class II 2011-08-17
K110663 PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) Sofradim Production FTL Class II 2011-08-11
K111333 ANTLIA III WOUND TREATMENT SYSTEM Innovative Therapies, Inc. OMP Class II 2011-08-08
K110027 SURGICAL FACE MASK; SURGICAL FACE MASK Angeline Group , Ltd. FXX Class II 2011-08-05
K112072 ATRICURE CRYO MODULE SYSTEM AtriCure, Inc. GEH Class II 2011-08-03
K111195 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS Ethicon Endo-Surgery, Inc. GDW Class II 2011-08-03
K110735 TANDA MAX OTC SYSTEM Pharos Life Corporation OHS Class II 2011-08-03
K111067 JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE Kunshan Jiehong Nonwoven Product Co., Ltd. FYA Class II 2011-08-02
K111611 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT Merit Medical Systems, Inc. ESW Class II 2011-07-29
K111393 SNAP (R) WOUND CARE SYSTEM Spiracur, Inc. OKO Class II 2011-07-28
K111213 VISION ONE LASER SYSTEM Lumenis, Inc. GEX Class II 2011-07-25
K110984 SLIM E30 II CO2 LASER Lasering S.R.L. ONG Class II 2011-07-22
K111006 CI-SNAP WOUND CARE SYSTEM Spiracur, Inc. OKO Class II 2011-07-21
K111280 V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT Kci USA, Inc. OMP Class II 2011-07-21
K110439 DOMAIN SURGICAL SYSTEM Domain Surgical, Inc. GEI Class II 2011-07-18
K110189 REPROCESSED ELECTROSURGICAL INSTRUMENT Ascent Healthcare Solutions NUJ Class II 2011-07-18
K111144 CANDELA GENTLELASE FAMILY OF LASERS Candela Corp. GEX Class II 2011-07-18
K110824 ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT Aragon Surgical, Inc. GEI Class II 2011-07-11
K111851 MEDIOSTAR NEXT Asclepion Laser Technologies GmbH GEX Class II 2011-07-08
K103714 ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA Ansell Healthcare Products, LLC KGO Class I 2011-07-07
K101306 SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A Fotona D.D. GEX Class II 2011-07-01
K110897 CORTEX CO2 / ER:YAG LASER SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2011-07-01
K102177 SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE Medline Industries, Inc. KGO Class I 2011-06-30
K111219 GMD UNIVERSAL URINARY INCONTINENCE SLING Generic Medical Device, Inc. OTN Class II 2011-06-30
K111672 MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER Pacific Hospital Supply Co., Ltd. GEI Class II 2011-06-29
K110243 MEDART DIODE LASER SYSTEM & ACCESSORIES Medart A/S GEX Class II 2011-06-28
K110695 BIPOLAR HF DEVICE Aesculap, Inc. GEI Class II 2011-06-28
K103417 HALIFAX BIOMEDICAL TANATLUM BEAD SET Halifax Biomedical, Inc. NEU Class II 2011-06-28
K111233 SUPRIS RETROPUBIC SLING SYSTEM Coloplast A/S OTN Class II 2011-06-24
K101049 WART FREEZE Koninklijke Utermohlen NV GEH Class II 2011-06-23
K110724 SURGICAL PROCEDURE PACKS Omnia Spa FYA Class II 2011-06-23
K110306 SOUND SURGICAL VASER 2.1 LIPO SYSTEM Sound Surgical Technologies, LLC QPB Class II 2011-06-23
K110907 PALOMAR ICON (TM) AESTHETIC SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2011-06-22
K102954 CUTERA QSWITCH LASER SYSTEM Cutera, Inc. GEX Class II 2011-06-22
K110647 RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS Smith & Nephew, Inc. OMP Class II 2011-06-22
K110946 ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE Galil Medical , Ltd. GEH Class II 2011-06-21
K110402 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER Cook Biotech, Inc. FTM Class II 2011-06-20
K110625 SAFETYMATE TALKING FIRST AID Safetymate, Inc. OVR Class I 2011-06-17
K102274 ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT Arvik Enterprises/ Mini Lap Technologies GAA Class I 2011-06-15
K100313 HYDROFIX SURGICAL SHEET Mimedx Group, Inc. FTL Class II 2011-06-14
K101990 ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 Ethicon Endo-Sugery, LLC GEI Class II 2011-06-13
K111020 ATRICURE DISSECTOR AtriCure, Inc. FTD Class II 2011-06-09
K110272 STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG Cardinal Health, Inc. KGO Class I 2011-06-08
K111111 ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO Ethicon Endo-Surgery, LLC GDW Class II 2011-06-08
K110728 IMESH TACKER Easylap , Ltd. GDW Class II 2011-06-08
K111442 V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... Covidien, Formerly US Surgical A Divison of Tyco H GAM Class II 2011-06-03
K110143 HET BIPOLAR ELECTROCAUTERY FORCEPS Het Systems, LLC GEI Class II 2011-06-02
K102461 FRACTORA Invasix , Ltd. GEI Class II 2011-06-02
K110268 FORCETRIAD ELECTROSURGICAL GENERATOR Covidien Lp, Formerly Know AS Valleylab, A Divison GEI Class II 2011-05-31
K103775 PEAK SUCTION COAGULATOR Peak Surgical, Inc. GEI Class II 2011-05-27

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.