FDA 510(k) Applications Submitted by JONATHAN S KAHAN

FDA 510(k) Number Submission Date Device Name Applicant
K110004 01/03/2011 ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS
K130254 02/01/2013 PROW FUSION NLT SPINE LTD
K080427 02/15/2008 WATCH-PAT MODEL 100S-2 ITAMAR MEDICAL
K080471 02/21/2008 RADIO BIOAQUACARE BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
K130459 02/22/2013 TRIA FAN SYSTEM TRIA BEAUTY, INC.
K120737 03/09/2012 TRIA LASER HAIR REMOVAL SYSTEM TRIA BEAUTY, INC.
K100874 03/30/2010 LIPOSONIX SYSTEM, MODEL 1 P00XXXX MEDICIS TECHNOLOGIES CORPORATION
K131198 04/26/2013 TIPI OTC CONTIPI LTD.
K121309 05/01/2012 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS
K061350 05/15/2006 LITHODIAMOND ULTRA PCK ELECTRONIC INDUSTRY & TRADE CO., LTD.
K131416 05/16/2013 NOVOPRESS MILKA, LLC
K081405 05/19/2008 XERACEM DOXA DENTAL AB
K894210 06/19/1989 SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS SHARPLAN LASERS, INC.
K031900 06/19/2003 HANDMASTER NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
K071713 06/22/2007 CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISIONS NETWORK
K041771 06/30/2004 TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM TWIN STAR MEDICAL, INC.
K141868 07/10/2014 TRIA FANP TRIA BEAUTY, INC.
K072068 07/27/2007 BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
K092306 07/29/2009 SECURACATH UNIVERSAL INTERRAD MEDICAL, INC.
K002500 08/14/2000 X-POSURE SYSTEM VERSION 2 RAD PRONOSCO A/S
K042217 08/16/2004 FLOWMEDIC, MODEL 220 FLOWMEDIC (ISRAEL) LTD
K092746 09/08/2009 MICRONJET 600 NANOPASS TECHNOLOGIES LTD.
K853901 09/20/1985 ENDO-LASE CD 40 FOR DERMATOLOGY ENDO LASE, INC.
K042600 09/23/2004 STANSION MATRIX SPINEWORKS, LLC
K112890 09/30/2011 NORMATEC MVP NORMATEC INDUSTRIES, LP
K053280 11/23/2005 PROBEAT HITACHI, LTD., POWER SYSTEMS GROUP
K093661 11/25/2009 COLONRING NITI SURGICAL SOLUTIONS LTD
K083677 12/11/2008 PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 COMMWELL LTD.
K133859 12/19/2013 WATCH-PAT200U (WP200U) ITAMAR MEDICAL LTD
K900076 01/04/1990 SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR SHARPLAN LASERS, INC.
K060050 01/06/2006 MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC.
K910051 01/07/1991 SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 SHARPLAN LASERS, INC.
K900153 01/11/1990 SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM SHARPLAN LASERS, INC.
K950116 01/11/1995 THERASTEAM PERSONAL STEAM INHALER KAZ, INC.
K920204 01/16/1992 INSTASCAN ADVANCED NMR SYSTEMS, INC.
K990160 01/19/1999 MICROTAC-BONE ANCHOR SYSTEM INFLUENCE, INC.
K060144 01/19/2006 SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS GALIL MEDICAL LTD.
K090164 01/22/2009 CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER BIOLITEC, INC.
K080180 01/24/2008 MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) OPTICAL IMAGING LTD.
K000245 01/27/2000 CSM STRETTA SYSTEM CONWAY STUART MEDICAL, INC.
K020280 01/28/2002 PULMOLAB EX671 EXERCISE TESTING SYSTEM MORGAN MEDICAL LTD.
K130234 01/30/2013 NUVON VITALS CHARTING SYSTEM NUVON, INC.
K030338 01/31/2003 ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 CURELIGHT LTD
K120299 01/31/2012 SRS ENDOSCOPIC STAPLING SYSTEM MEDIGUS, LTD.
K120301 01/31/2012 MEDIGUIDE TECHNOLOGY ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
K140255 01/31/2014 STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) POLLOGEN LTD
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K910451 02/01/1991 CARD GUARD, MODEL CG-2000A MEDTECH INDUSTRIES, INC.
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K020399 02/06/2002 RESPERATE; MODEL RR-150 INTERCURE LTD.
K090312 02/06/2009 TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC TRIA BEAUTY, INC.
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K020470 02/12/2002 MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE BYPASS LTD.
K030469 02/12/2003 LAPAROSHIELD CONDITIONED INSUFFLATION SET PALL MEDICAL
K030474 02/12/2003 PH BUFFERING PLASTIC APPLICATOR TAMPON ROSTAM LTD.
K910723 02/20/1991 BIODEGRADABLE SURGICAL STAPLE INSTRUMENT MAKAR, INC.
K070482 02/20/2007 ISIS GALIL MEDICAL LTD.
K940859 02/23/1994 PACSPRO I ADVANCED VIDEO PRODUCTS, INC.
K950836 02/24/1995 REDFIELD INFRARED COAGULATOR HOGAN & HARTSON
K920865 02/25/1992 SHARPLAN 2100,3000,SHARPLASER 65, 40 SHARPLAN LASERS, INC.
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K990663 03/01/1999 INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 MEDTECH LTD.
K100606 03/03/2010 VATEA ENDONTIC IRRIGATION SYSTEM REDENT NOVA LTD
K910884 03/04/1991 CARD GUARD, MODELS CG-6000 & CG-7000 CARD GUARD SCIENTIFIC SURVIVAL, LTD.
K980838 03/04/1998 REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC.
K990717 03/04/1999 FIXION INTRAMEDULLARY NAILING SYSTEM DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
K000731 03/06/2000 MODIFICATION TO RTA RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD.
K030700 03/06/2003 CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT BIOLITEC, INC.
K941086 03/08/1994 PACSPRO II ADVANCED VIDEO PRODUCTS, INC.
K891345 03/09/1989 MOBILIMB CPM SHOULDER UNIT TORONTO MEDICAL CORP.
K980913 03/10/1998 CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 GALIL MEDICAL LTD.
K020835 03/14/2002 CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 BIOLITEC, INC.
K990850 03/15/1999 COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL COOPERSURGICAL, INC.
K990852 03/15/1999 COOPERSURGICAL INFRARED COAGULATOR COOPERSURGICAL, INC.
K990855 03/15/1999 COOPERSURGICAL INFRARED COAGULATOR FOR ENT COOPERSURGICAL, INC.
K010791 03/15/2001 REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) ADSIS LTD.
K020856 03/15/2002 SPATOUCH PHOTOEPILATION SYSTEM RADIANCY (ISRAEL) LTD.
K110767 03/18/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC.
K010837 03/20/2001 HANDMASTER NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.
K030897 03/21/2003 SKINSTATION RADIANCY (ISRAEL) LTD.
K911308 03/22/1991 CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE MEDICAL EQUIPMENT DESIGNS, INC.
K050758 03/23/2005 CHEMPAQ XBC ANALYZER CHEMPAQ A/S
K070805 03/23/2007 ULTRAWAVE II EX 1320 QUANTA SYSTEM, S.P.A.
K010901 03/26/2001 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K120956 03/30/2012 VSP SYSTEM MEDICAL MODELING INC
K050824 03/31/2005 100W CERALAS D 980 LASER SYSTEM, MODEL D100 BIOLITEC, INC.
K941559 04/01/1994 PARADERM -585M DERMATOLOGICAL LASER PARADIGM LASERS, INC.
K010988 04/02/2001 FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K911523 04/04/1991 MODIFICATION TO MODEL 90-1460 LASER ADAPTER LIFESTREAM INT'L, INC.
K021102 04/04/2002 DM SLEEVE EMILY IKER M.D., A.P.C.
K070968 04/05/2007 CHOY COMPRESSION FRAME CHOY MEDICAL TECHNOLOGIES, INC.
K090978 04/06/2009 UC-CARE WARMING SYSTEM UC-CARE LTD.
K081015 04/09/2008 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC.
K951678 04/11/1995 HI SONIC 2000 DIGITAL HEARING INSTRUMENT HEARING INNOVATIONS, INC.
K971358 04/11/1997 BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM ARTHREX, INC.
K911648 04/12/1991 REDFIELD INFRARED COAGULATOR REDFIELD CORP.
K941819 04/13/1994 LIQUID OXYGEN STORAGE SUBSYSTEM HOGAN & HARTSON
K091100 04/16/2009 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL, INC.
K951775 04/17/1995 CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) CERAMOPTEC, INC.
K941909 04/19/1994 MEGA BEAM LATERAL FIRE HOGAN & HARTSON
K021261 04/19/2002 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 GALIL MEDICAL LTD.
K051007 04/20/2005 ACCU02 SYSTEM MITI CORP.
K091175 04/22/2009 GRIND NO MORE VERSION 2 AND 3 RANIR LLC
K871590 04/24/1987 VOCALTECH VOCAL FEEDBACK DEVICE VOCALTECH C/O HOGAN & HARTSON
K051052 04/25/2005 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) GALIL MEDICAL LTD.
K101172 04/26/2010 RDT3 HANDPIECE HEAD MODEL RDT3 REDENT NOVA LTD
K991517 04/30/1999 CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 GALIL MEDICAL LTD.
K011344 05/02/2001 INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 COLLINS MEDICAL, INC.
K893473 05/04/1989 COMMUNI-CALL CAREPARTNERS, INC.
K942182 05/04/1994 MEGABEAM DENTAL FIBER CERAM OPTEC, INC.
K871748 05/05/1987 THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE THE BUDDY SYSTEMS, INC.
K051168 05/05/2005 BARRX HALO 360 SYSTEM, MODEL 1100C-115A BARRX MEDICAL, INCORPORATED
K942229 05/06/1994 MOTIVATOR FTR 2000 HOGAN & HARTSON
K871791 05/07/1987 BLOXOM IRRIGATOR I.B. BLOXOM C/O HOGAN & HARTSON
K981631 05/07/1998 INFLUENCE CLIP SYSTEM INFLUENCE, INC.
K071295 05/08/2007 100W CERALAS D 980NM DIODE LASER BIOLITEC, INC.
K041290 05/13/2004 RTA MODEL D RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD.
K091425 05/13/2009 QUANTUM M COMPOSITE NAILING SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD.
K051268 05/16/2005 RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT RADIANCY, LTD.
K071375 05/16/2007 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K952340 05/19/1995 MEGABEAM ASPIRATING ENDOCULAR PROBE CERAMOPTEC, INC.
K111407 05/19/2011 TRIPORT, TRIPORT+, TRIPORT15, QUADPORT ADVANCED SURGICAL CONCEPTS
K011589 05/23/2001 CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M BYPASS LTD.
K952471 05/26/1995 BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD BIOSCIENCE, INC.
K991792 05/26/1999 CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE INFLUENCE, INC.
K932591 05/28/1993 ENDO-JUDGE SYNERGISTIC MEDICAL TECHNOLOGIES, INC.
K061502 05/31/2006 MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 MEDIC4ALL (ISRAEL) LTD.
K021851 06/05/2002 DIGITAL CLINICAL THERMOMETER, MODEL KD-193 K-JUMP HEALTH CO., LTD.
K011779 06/07/2001 AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM AVID CARE CORP.
K942740 06/10/1994 SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM SHARPLAN LASERS, INC.
K852507 06/12/1985 ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION ENDO LASE, INC.
K011839 06/12/2001 DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C DOXA CERTEX AB
K061674 06/14/2006 RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD.
K011877 06/15/2001 FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM CARL ZEISS JENA GMBH
K992038 06/16/1999 POCKETSPACER FERRARIS MEDICAL, INC.
K091780 06/17/2009 GUIDED MEASUREMENT CATHETER (GMC) MEDIGUIDE, LTD.
K091781 06/17/2009 GUIDED MEDICAL POSITIONING SYSTEM (GMPS) MEDIGUIDE, LTD.
K131758 06/17/2013 SURGEN U POLLOGEN LTD
K982155 06/18/1998 SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM INFLUENCE, INC.
K011950 06/21/2001 SEEDNET, MODEL FP6T5, FP5T5, FP5T3 GALIL MEDICAL LTD.
K051671 06/22/2005 RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY RADIANCY (ISRAEL) LTD.
K022099 06/27/2002 SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S HDC CORP.
K061905 07/05/2006 HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 MEDCON LTD.
K923289 07/06/1992 SURVALENT II ORAL THERMOMETER EPSON AMERICA, INC.
K992277 07/07/1999 STAPLETAC BONE ANCHOR SYSTEM INFLUENCE, INC.
K092066 07/08/2009 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE ANDREW TECHNOLOGIES, LLC
K933345 07/09/1993 NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC NOBLES-LAI ENGINEERING, INC.
K923605 07/10/1992 MODIFIED SHARPLAN 1041 SHARPLAN LASERS, INC.
K923855 07/10/1992 SHARPULSE SHARPLAN LASERS, INC.
K081982 07/11/2008 WATCH-PAT 200S-2 (WP200S-2) ITAMAR MEDICAL
K132151 07/11/2013 SRS ENDOSCOPIC STAPLING SYSTEM MEDIGUS, LTD.
K953294 07/14/1995 CANDELA CRYOSYSTEM CS-5 CANDELA LASER CORP.
K972651 07/14/1997 IN-SLING INFLUENCE, INC.
K002135 07/14/2000 SLEEPSTRIP DISPOSABLE APNEA SCREENER INFLUENT LTD.
K923543 07/16/1992 MIS CERAMOPTEC, INC.
K982482 07/16/1998 HANDMASTER NMS1 N.E.S.S. NUROMUSCULAR ELECTRICAL STIMULATION SYST
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K943444 07/18/1994 MEGABEAM LATERAL FIRE CERAMOPTEC, INC.
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K953406 07/20/1995 EBI X FIX DYNAFIX SYSTEM (DFS) ELECTRO-BIOLOGY, INC.
K953412 07/20/1995 CANDELA MODEL PLTL-1 LASER SYSTEM CANDELA LASER CORP.
K943526 07/21/1994 MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC.
K943527 07/21/1994 MEGABEAM LATERAL FIRE CERAMOPTEC, INC.
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K062127 07/25/2006 MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) MEDIC4ALL (ISRAEL) LTD.
K992482 07/26/1999 DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) RADIANCY, LTD.
K112182 07/28/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC.
K082138 07/29/2008 AIRGENT, MODEL AG7000010 PERFACTION, INC.
K102135 07/29/2010 VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM NUVON, INC.
K072106 07/31/2007 150W CERALAS D 980NM DIODE LASER BIOLITEC, INC.
K142086 07/31/2014 NIO -INTRAOSSEOUS DEVICE WAISMED LTD.
K032383 08/01/2003 MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD
K012497 08/03/2001 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 GALIL MEDICAL LTD.
K982721 08/04/1998 BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM BIONX IMPLANTS, INC.
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K012545 08/07/2001 ARAMIS DERMATLOGIC LASER LUMEDICS, LTD.
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K092933 09/23/2009 SAF (SELF ADJUSTING FILE) REDENT-NOVA LTD.
K062891 09/26/2006 PROTON THERAPY SYSTEM INDIANA UNIVERSITY CYCLOTRON FACILITY
K062940 09/28/2006 BONE INJECTION GUN (B.I.G.) WAISMED LTD.
K072779 09/28/2007 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC.
K062991 09/29/2006 GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE LIGHT BIOSCIENCE, LLC
K082919 09/30/2008 UC-CARE POSITIONING SYSTEM UC-CARE MEDICAL SYSTEMS LTD
K102905 09/30/2010 GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) MEDIGUIDE, LTD.
K033181 10/01/2003 SPR SYSTEM RADIANCY (ISRAEL) LTD.
K033183 10/01/2003 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 CURELIGHT LTD
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K944928 10/06/1994 PY30, PY60, PY80 HUTTINGER MEDIZINTECHNIK GMBH & CO KG
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