FDA 510(k) Applications for Medical Device Product Code "HQC"
(Unit, Phacofragmentation)

FDA 510(k) Number Applicant Device Name Decision Date
K002986 A.R.C. LASER AG A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 11/29/2000
K003512 A.R.C. LASER AG LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II 02/08/2001
K111697 ABBOTT MEDICAL OPTICS INC AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM 09/27/2011
K151636 ABBOTT MEDICAL OPTICS INC AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control 10/19/2015
K133115 ABBOTT MEDICAL OPTICS INC COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK 02/27/2014
K111882 ABBOTT MEDICAL OPTICS INC LAMINAR FLOW PHACO TIPS 11/07/2011
K121721 ABBOTT MEDICAL OPTICS INC LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) 10/15/2012
K111446 ABBOTT MEDICAL OPTICS INC SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM 12/21/2011
K103023 ABBOTT MEDICAL OPTICS INC UNIT, PHACOFRAGMENTATION 06/01/2011
K151783 Abbott Medical Optics Inc. COMPACT INTUITIV Multiple-Use Pack 09/02/2015
K160236 Abbott Medical Optics Inc. Dual Pump Pack 04/27/2016
K050648 ADVANCED MEDICAL OPTICS, INC. SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK 04/05/2005
K060366 ADVANCED MEDICAL OPTICS, INC. THE AMO OPHTHALMIC SURGICAL SYSTEM 04/07/2006
K854225 ADVANCED MEDICAL TECHNOLOGY, INC. ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS 12/27/1985
K862777 ADVANCED MEDICAL TECHNOLOGY, INC. MODEL A-8000 ULTRASONIC HANDPIECE CORD 08/11/1986
K853189 AESTHETECH CORP. CREAT BRAND I/A PACK CREAT BRAND PHACO PACK 09/24/1985
K063583 ALCON ALCON VISION SYSTEM 05/09/2008
K955789 ALCON LABORATORIES ALCON SERIES 20000 LEGACY MACKOOL SYSTEM 03/21/1996
K952213 ALCON LABORATORIES ALCON SERIES 20000 LEGACY PHACOEMULSIFIER 08/09/1995
K911808 ALCON LABORATORIES GEMINI OPHTHALMIC SURGERY SYSTEM 06/25/1991
K981103 ALCON LABORATORIES TURBOSONICS LIMITED REUSE ULTRASONIC TIP 06/23/1998
K121555 ALCON LABORATORIES, INC. CENTURION VISION SYSTEM 12/21/2012
K021566 ALCON LABORATORIES, INC. INFINITI 07/02/2002
K120732 ALCON LENSX, INC. LENSSX LASER SYSTEM 09/06/2012
K093210 ALCON MANUFACTURING, LTD. AQUALASE CAPSULE WASH TIP 03/04/2010
K101285 ALCON MANUFACTURING, LTD. CONSTELLATION VISION SYSTEM 11/12/2010
K112425 ALCON MANUFACTURING, LTD. INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE 11/21/2011
K120912 ALCON MANUFACTURING, LTD. INFINITI(R) VISION SYSTEM 06/15/2012
K091777 ALCON RESEARCH, LTD. ALCON ULTRACHOPPER 10/20/2009
K161794 Alcon Research, Ltd. CENTURION Vision System (Active SentryTM) 04/14/2017
K082845 ALCON RESEARCH, LTD. INFINITI VISION SYSTEM WITH OZIL IP 02/12/2009
K902798 ALCON SURGICAL, INC. AUTOMATED HYDROSONICS(TM) 08/28/1990
K924235 ALLERGAN MEDICAL OPTICS AMO ELITE 12/23/1992
K951462 ALLERGAN MEDICAL OPTICS AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM 06/15/1995
K925254 ALLERGAN MEDICAL OPTICS AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 01/07/1993
K971186 ALLERGAN, INC. AMO DIPLOMAX/OPSYS CONSOLE 06/13/1997
K962402 ALLERGAN, INC. AMO PRESTIGE DAY PACK (ALLERGAN, INC.) 09/19/1996
K003638 ALLERGAN, INC. MOJAVE CATARACT EXTRACTION SYSTEM 02/13/2001
K840495 ALLTEK, INC. MANUAL IRRIGATING/ASPIRATING UNIT 06/19/1984
K830812 ALPHAMEDIX, INC. ALPHAMEDIX I/A HAND-PIECE, 500-001 06/08/1983
K833405 AMERICAN MEDICAL OPTICS IRRIGATION ASPIRATION KIT 01/06/1984
K844150 AMERICAN MEDICAL OPTICS MEDICAL OPTICS PHACOEMULSIFICATION KIT 12/11/1984
K931357 AMERICAN OPTICAL CORP. AOD4000 DISPOSABLE PAK 01/25/1994
K950880 AMERICAN OPTICAL CORP. AOI UNIVERSAL ULTRASONIC HANDPIECE 05/26/1995
K931358 AMERICAN OPTICAL CORP. AORP4000 REUSABLE PAK 02/22/1994
K931354 AMERICAN OPTICAL CORP. P4000 PHACOEMULSIFIER 02/22/1994
K950881 AMERICAN OPTICAL CORP. PHACO TIP 09/06/1995
K952331 AMERICAN OPTISURGICAL, INC. AOI LC-40 PHACOEMULSIFIER 08/16/1995
K953539 AMERICAN OPTISURGICAL, INC. DM001 DISPOSABLE PACK 12/26/1995
K020527 AMERICAN OPTISURGICAL, INC. HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 07/09/2002
K953538 AMERICAN OPTISURGICAL, INC. RM001 REUSABLE 12/26/1995
K080803 AMERICAN OPTISURGICAL, INC. VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 09/22/2008
K833617 AMERICAN SURGICAL CO., INC. EXTRA PLUS TM 12/28/1983
K833697 AMERICAN SURGICAL CO., INC. EXTRA SENSORY PAK-DISPOS. ACCESS 12/28/1983
K834158 AMERICAN SURGICAL CO., INC. EXTRA SENSORY PLUS 12/28/1983
K834159 AMERICAN SURGICAL CO., INC. PHACOTRON PLUS 12/28/1983
K834161 AMERICAN SURGICAL CO., INC. UNIVERSAL PAC 12/28/1983
K945583 ARENT FOX OCUSYSTEM(ART) 02/13/1995
K002031 ASCLEPION-MEDITEC AG PHACOFRAGMENTATION SYSTEM MEGATRON 12/27/2000
K850532 ATLANTIC OPTICAL SYSTEMS, INC. ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK 04/15/1985
K831701 ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK 07/12/1983
K133486 BAUSCH & LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM 03/12/2014
K133242 BAUSCH & LOMB STELLARIS VISION ENHANCEMENT SYSTEM 02/14/2014
K082132 BAUSCH & LOMB, INC BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK 08/28/2008
K063331 BAUSCH & LOMB, INC. BAUSCH & LOMB NGX MICROSURGICAL SYSTEM 12/19/2006
K082473 BAUSCH & LOMB, INC. BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM 01/05/2009
K041998 BAUSCH & LOMB, INC. PHACO CHOP NEEDLES 08/16/2004
K101325 BAUSCH & LOMB, INC. STELLARIS PC VISION ENHANCEMENT SYSTEM 08/17/2010
K073023 BAUSCH & LOMB, INC. STERILS SINGLE-USE I/A HANDPIECES 03/12/2008
K033653 BAUSCH & LOMB, INC. VENTURI PHACO PACK 12/17/2003
K170052 Bausch + Lomb Stellaris Elite vision enhancement system 04/19/2017
K162342 Bausch + Lomb Stellaris Elite Vision Enhancement System 03/24/2017
K833800 BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION BEECHER 20 GA. PROBE 01/04/1984
K022833 BENJAMIN BIOMEDICAL, INC. BENJAMIN ENVOY PHACO HANDPIECE 09/09/2002
K771644 BERKELEY BIO-ENGINEERING FRAGMATOME MODEL 820 09/26/1977
K840063 CALLIOPE CORP. CATAREX VITRECUTTER I/A DISPOS. CUT 10/05/1984
K840181 CALLIOPE CORP. CATAREX/ULTRASONICS KIT 10/05/1984
K925631 CHIRON INTRAOPTICS PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE 07/29/1993
K843276 CHIRON VISION CORP. IOCARE CONVERTER KIT 05/09/1985
K834340 CHIRON VISION CORP. IOCARE IRRIGATION & ASPIRATION PACK 04/05/1984
K843275 CHIRON VISION CORP. IOCARE IRRIGATION/ASPIRATION PACK 11/27/1984
K843277 CHIRON VISION CORP. IOCARE PHACOEMULSIFICATION PACK 11/27/1984
K843278 CHIRON VISION CORP. IOCARE ULTRASONIC TITANIUM TIPS 11/27/1984
K921607 CHIRON VISION CORP. IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE 06/30/1992
K944993 CHIRON VISION CORP. IOLAB.SITE CD PHACOEMULSIFICATION MODULE 10/12/1995
K944994 CHIRON VISION CORP. IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE 03/14/1995
K944995 CHIRON VISION CORP. IOLAB/SITE PERISTALTIC MODULE 10/05/1995
K883199 CHIRON VISION CORP. MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM 09/15/1988
K922595 CHIRON VISION CORP. MODIFIED SITE MACROBORE PHACO NEEDLE 08/31/1992
K840965 CHIRON VISION CORP. SITE COAXIAL I/A HANDPIECE 30 TIP 05/09/1984
K842458 CHIRON VISION CORP. SITE SIMCOE STYLE I/A HANDPIECE 08/15/1984
K844666 CHIRON VISION CORP. SITE ULTRASONIC EMULSIFICATION MODULE OP 12/27/1984
K960414 CHIRON VISION CORP. SYNERGIST POWER PACK 04/24/1996
K843319 CILCO, INC. CILCO I/A SURGICAL PACK 02/14/1985
K954237 CIRCUIT TREE CIRCUIT TREE PHACO HANDPIECE 12/08/1995
K954242 CIRCUIT TREE CIRCUIT TREE PHACOEMULSIFIER 12/01/1995
K981989 CIRCUIT TREE THE WAVE DIGITAL PHACO SYSTEM 08/25/1998
K962431 CIRCUIT TREE MEDICAL, INC. CTM DISPOSABLE PAK 07/23/1996
K962430 CIRCUIT TREE MEDICAL, INC. CTM REUSABLE PAK 07/23/1996
K832413 CLARK POOL & ASSOC. SIAS IRRIGATION/ASPIRATION SYSTEM 10/04/1983
K842979 COOPERVISION, INC. CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA 11/27/1984
K890635 COOPERVISION, INC. CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. 05/09/1989
K853070 COOPERVISION, INC. COOPER VISION SYSTEM VI U/S MODULE 08/20/1985
K854375 COOPERVISION, INC. COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR 12/27/1985
K842945 COOPERVISION, INC. COOPERVISION SYSTEM VI 12/11/1984
K833783 COOPERVISION, INC. DISPOS. I/A & IRRIGATION HANDPIECES 03/05/1984
K833465 COOPERVISION, INC. DISPOSABLE FIBER OPTIC ILLUMINATOR 03/15/1984
K833784 COOPERVISION, INC. DISPOSABLE I/A HANDPIECE 02/21/1984
K831836 COOPERVISION, INC. EPSILON ULTRASONIC TIP 06/30/1983
K871854 COOPERVISION, INC. IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS 07/27/1987
K850149 COOPERVISION, INC. KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA 04/15/1985
K850275 COOPERVISION, INC. KCP PAK #2 CONVENIENCE PACK MODIFICATION 04/15/1985
K850148 COOPERVISION, INC. KCP PAK CONVENIENCE PACK 04/15/1985
K843386 COOPERVISION, INC. MENDEZ U/S CYSTOTOME 11/27/1984
K812126 COOPERVISION, INC. ULTRASONIC TIPS 09/18/1981
K883097 D.O.R.C. INTL. B.V. GV3000 PHACOEMULSIFIER/FRAGMENTER 12/06/1988
K965127 DGH TECHNOLOGY, INC. DGH MODEL 9000 03/17/1997
K860770 DRAVON MEDICAL, INC. AM-100 I/A AMPAC 04/21/1986
K081877 DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS 01/05/2009
K142877 DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) 03/13/2015
K862064 ENTRAVISION, INC. ENTRAVISION EP-500 I/A ECCO PACK 06/19/1986
K862063 ENTRAVISION, INC. ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE 06/19/1986
K832423 ENVISION, INC. ENVISION G21 I/A ENPAK 09/12/1983
K832424 ENVISION, INC. ENVISION G31 P.E. PAK 09/12/1983
K984143 FIBRA SONICS, INC. FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM 02/16/1999
K802381 FIBRA SONICS, INC. LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. 12/17/1980
K834453 FIBRA SONICS, INC. PHACO FRAGMENTOR GT-1 03/16/1984
K872362 FRIGITRONICS OF CONNECTICUT, INC. FRIGITRONICS ACC-1000 CAPSULE CUTTER 07/27/1987
K864056 GRIESHABER & CO. GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT 10/31/1986
K863444 GRIESHABER & CO. GRIESHABER GLOBAL CONTROL TUBING SET 10/31/1986
K952468 HI-LINE MEDICAL HI-LINE MEDICAL PHACOEMULSIFIER TIP 08/24/1995
K915457 INNOVATIVE MEDICAL SYSTEMS, INC. PHACO 20/20 SYSTEM I 02/24/1992
K915456 INNOVATIVE MEDICAL SYSTEMS, INC. PHACO 3000 LINEAR 02/12/1992
K841072 INNOVATIVE SURGICAL PRODUCTS INC. IRRIGATION, ASPIRATION TUBING SETS 03/29/1984
K840695 INNOVATIVE SURGICAL PRODUCTS INC. PHACOEMULSIFICATION KITS 05/22/1984
K834543 INTERMEDICS INTRAOCULAR, INC. OCUCARE ULTRASOUND TIP & FREEDOM PACK 03/16/1984
K823088 INTL. OPHTHALMIC INDUSTRIES CORP. ASPITRON 04/06/1983
K894511 INTL. OPHTHALMIC INDUSTRIES CORP. MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT 10/17/1989
K961658 INTL. OPHTHALMIC INDUSTRIES CORP. MEGATRON OPHTHALMIC SURGICAL SYSTEM 07/23/1996
K894512 INTL. OPHTHALMIC INDUSTRIES CORP. PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS 10/17/1989
K902876 INTRAOPTICS SURGICAL, INC. "PHACOTRON SYSTEMS PLUS III" PHACOEMULSIFIER ASPI. 09/18/1990
K863729 IPAX, INC. "OPHTHALMIC FITLER MICRO CAPSULE" 10/10/1986
K833961 IPAX, INC. I/A PLUS PAK SURGICAL SYSTEM 03/12/1984
K864726 IPAX, INC. I/A/KPE TIP 01/20/1987
K914172 IPAX, INC. KPE 230 AM 10/25/1991
K833962 IPAX, INC. KPE PLUS-PAK SURGICAL SYSTEM 03/12/1984
K915118 IPAX, INC. PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE 12/27/1991
K863209 IPAX, INC. US PLUS-PAK(R) SURGICAL SYSTEM 09/08/1986
K782141 KEELER OPTICAL PRODUCTS LTD. LEVIGATOR, KEELER PHOKO 01/26/1979
K871649 KOREA ASAHI OPTICAL CO., LTD. CLASSIC 70 LENS 05/29/1987
K122829 LENSAR, INC. LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS 12/03/2012
K091915 LENSTEC, INC. FLUID ISOLATION DEVICE 10/27/2009
K913530 LOOK, INC. LOOK VISCODISSECTOR 10/21/1991
K933627 M. IMONTI AND ASSOCIATES INC., PHACOFRAGMENTOR TIP 01/25/1994
K950800 M. IMONTI AND ASSOCIATES INC., PRO-PAK FOR OMS DIPLOMATE 05/22/1995
K933503 M. IMONTI AND ASSOCIATES INC., PRO-PHACO HANDPIECE 01/06/1994
K860957 MEDICAL CORP. OF AMERICA DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT. 06/02/1986
K860956 MEDICAL CORP. OF AMERICA KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST. 06/02/1986
K854116 MEDICAL CORP. OF AMERICA PHACO PACKS, 1A PACKS & PACK COMPONENTS 12/27/1985
K853883 MEDICAL CORP. OF AMERICA TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR 10/08/1985
K851009 MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. INFUSION SLEEVE - OPHTHALMIC 04/03/1985
K834537 MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. MICRO VIT FRAGMENTATION SYSTEM 03/16/1984
K832529 MEDICAL SURGICAL DESIGNS M.S.D. ASPIRATOR 01/04/1984
K904612 MEDICAL TECHNICAL PRODUCTS I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) 12/26/1990
K940088 MEDICAL TECHNICAL PRODUCTS MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE 08/04/1994
K940084 MEDICAL TECHNICAL PRODUCTS MODEL 2000 OPHTHALMIC SURGICAL SYSTEM 06/17/1994
K871473 MEDICAL TECHNICAL PRODUCTS PART #860065 IA PAK & PART #860060 IA PAK 08/10/1987
K940083 MEDICAL TECHNICAL PRODUCTS STANDARD PHACO TIP 15, 30, 45, 60 09/28/1994
K974469 MENTOR CORP. MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL 02/24/1998
K955245 MENTOR O & O, INC. MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM 02/12/1996
K912904 MENTOR O & O, INC. MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM 06/11/1992
K832997 MIAMI EYE TECHNOLOGY, INC. EPA AUTOMATED INFUSION POLE 10/04/1983
K002812 MICHAEL REYNARD, M.D. IRIS RETRACTING PHACOEMULSIFICATION SLEEVE 11/08/2000
K964018 MICHAEL REYNARD, M.D. PHACOILLUMINATOR - FIBEROPTIC SLEEVE 02/26/1997
K860989 MICROSURGICAL SYSTEMS, INC. SITE DISPOSABLE CASSETTE 05/06/1986
K953959 MICROSURGICAL TECHNOLOGY, INC. PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES 11/17/1995
K943672 MICROSURGICAL TECHNOLOGY, INC. PHACO NEEDLES AND TIPS 10/13/1994
K030957 MILVELLA PTY. LTD. PERFECT CAPSULE 08/20/2003
K960287 NIDEK, INC. HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM 11/05/1996
K924260 NIDEK, INC. NIDEK CV-12000 03/26/1993
K901686 NIDEK, INC. NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 06/08/1990
K951824 NIDEK, INC. STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) 07/19/1995
K881635 NOETIX, INC. NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM 07/01/1988
K890825 O.R. SPECIALTIES, INC. "JUMPER PACK #203" 05/26/1989
K880062 O.R. SPECIALTIES, INC. C-MATE #CMU 1001 03/07/1988
K923630 O.R. SPECIALTIES, INC. PHACO NEEDLES 1000-R & 1000-O NEEDLES 04/06/1994
K891161 O.R. SPECIALTIES, INC. VITRECTOMY PACK #J120 05/26/1989
K943379 OASIS MEDICAL, INC. PHACO TIPS FOR PHACO FRAGMENTATION MACHINES 10/11/1994
K950798 OASIS MEDICAL, INC. POSTERIOR CAPSULE SHIELD 05/22/1995
K832559 OCULAR INNOVATIONS, INC. OCUCARE FREEDOM PACK 09/29/1983
K830902 OCULAR INNOVATIONS, INC. OCUCARE PACK 05/16/1983
K972253 ODYSSEY TECHNOLOGIES, INC. P3 UNIVERSAL PHACO HANDPIECE 07/29/1997
K972252 ODYSSEY TECHNOLOGIES, INC. VISTA UNIVERSAL HANDPIECE 07/29/1997
K133562 OERTLI INSTRUMENTE AG CATARHEX 3 08/12/2014
K946054 OPTICAL MICRO SYSTEMS, INC. DIPLOMAX 07/11/1995
K844373 OPTICAL MICRO SYSTEMS, INC. O.M.S. ULTRA-PHACO 12/19/1985
K950218 OPTICAL MICRO SYSTEMS, INC. OMS SLIMLINE PHACO HANDPIECE 07/17/1995
K935223 OPTICAL MICRO SYSTEMS, INC. OPHTHALMIC SURGICAL SYSTEM 03/14/1994
K924033 OPTRO-MECHANICS (USA) CORP. ALTEX MODEL UST-3000E 11/05/1992
K971795 PARADIGM MEDICAL INDUSTRIES, INC. AUTOMATED CHAMBER MAINTENANCE MODULE 07/14/1997
K974719 PARADIGM MEDICAL INDUSTRIES, INC. PHACOPAK 01/20/1998
K953447 PARADIGM MEDICAL INDUSTRIES, INC. PRECISIONIST THIRTY THOUSAND 10/13/1995
K981109 PARADIGM MEDICAL INDUSTRIES, INC. QUITETIP 06/09/1998
K900493 PARADIGM MEDICAL, INC. THE PRECISIONIST 08/28/1990
K031404 PHACOR INC., A SANTEN COMPANY DIGNITY OPHTHALMIC SURGICAL SYSTEM 05/22/2003
K851674 PHAKOSYSTEMS, INC. PHAKOSYSTEMS MODEL CES 4100 08/05/1985
K833642 PHAROSYSTEMS, INC. PHAKO SYSTEMS VIA 2000 03/05/1984
K960811 SAINT JOHN'S PLAZA MEDICAL GROUP PHACOSCOPE 10/02/1996
K973749 SCIERAN TECHNOLOGIES, INC. FRAG COMMANDER 12/08/1997
K980085 SCIERAN TECHNOLOGIES, INC. PHACO COMMANDER 02/24/1998
K921135 SITE MICROSURGICAL SYSTEMS, INC. IOLAB POWER I.V. POLE 06/03/1992
K925828 SITE MICROSURGICAL SYSTEMS, INC. MODIFIED SITE TXR SYSTEMS 02/16/1994
K912902 SITE MICROSURGICAL SYSTEMS, INC. PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE 12/17/1991
K904151 SITE MICROSURGICAL SYSTEMS, INC. SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE 12/05/1990
K912739 SITE MICROSURGICAL SYSTEMS, INC. SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE 08/28/1991
K883099 SITE MICROSURGICAL SYSTEMS, INC. SITE MACROBORE PHACO NEEDLE 09/15/1988
K892911 SITE MICROSURGICAL SYSTEMS, INC. SITE PERISTALTIC CASSETTE 05/17/1989
K861060 SITE MICROSURGICAL SYSTEMS, INC. SITE PHACO DISPOSABLE CASSETTE 05/06/1986
K892852 SITE MICROSURGICAL SYSTEMS, INC. SITE PHACO PLUS INFUSION SLEEVE 06/08/1989
K904183 SITE MICROSURGICAL SYSTEMS, INC. SITE PHACOEMULSIFICATION HANDPIECE 12/05/1990
K864301 SITE MICROSURGICAL SYSTEMS, INC. SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) 12/15/1986
K871485 SITE MICROSURGICAL SYSTEMS, INC. SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE 06/03/1987
K882103 SITE MICROSURGICAL SYSTEMS, INC. SITE ULTRASONIC I/A PHACO NEEDLE 07/01/1988
K931866 SITE MICROSURGICAL SYSTEMS, INC. SITE'S CD II PHACOEMULSIFICATION HANDPIECE 11/12/1993
K872611 SOLOS OPHTHALMOLOGY SOLOS EYESITE CAP SLEEVE 08/10/1987
K874334 SOLOS OPHTHALMOLOGY SOLOS SINGLE USE TITANIUM TIP 01/11/1988
K890080 SONIC NEEDLE CORP. PHACOEMULSIFIER MODEL 100 04/06/1989
K850899 STAAR SURGICAL CO. I/A BAC STOP KIT 03/29/1985
K852208 STAAR SURGICAL CO. PHACO-BAC STOP FILTER KIT 08/20/1985
K850900 STAAR SURGICAL CO. PHACO-BAC STOP KIT 03/29/1985
K884241 STAAR SURGICAL CO. STAAR PHACO XL SMALL INCISION SYSTEM 02/17/1989
K020734 STAAR SURGICAL CO. SURGE-FREE ASPIRATION ADAPTER 05/16/2002
K831172 STAAR SURGICAL CO. ULTRAKIT 06/08/1983
K954340 STORZ STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE 12/14/1995
K926512 STORZ STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE 09/09/1993
K961310 STORZ INSTRUMENT CO. STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) 06/27/1996
K962131 STORZ INSTRUMENT CO. STORZ D4600 AIR EXCHANGE LINE PACK 08/23/1996
K960003 STORZ INSTRUMENT CO. STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION 08/29/1996
K960024 STORZ INSTRUMENT CO. STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH 09/20/1996
K953078 STORZ INSTRUMENT CO. STORZ DP4101 BASIC I/A PACK 08/07/1995
K955901 STORZ INSTRUMENT CO. STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX 03/28/1996
K961820 STORZ INSTRUMENT CO. STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK 07/25/1996
K961874 STORZ INSTRUMENT CO. STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK 08/06/1996
K961831 STORZ INSTRUMENT CO. STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK 08/06/1996
K833064 STORZ INSTRUMENT CO. STORZ EXTRA 01/04/1984
K951463 STORZ INSTRUMENT CO. STORZ I/A HANDPIECES 10/27/1995
K971439 STORZ INSTRUMENT CO. STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES 06/17/1997
K952259 STORZ INSTRUMENT CO. STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES 06/14/1995
K935926 STORZ INSTRUMENT CO. STORZ PHACO AND FRAG HANDPIECES 11/28/1994
K946176 STORZ INSTRUMENT CO. STORZ PHACOEMULSIFICATION NEEDLES 02/14/1995
K946227 STORZ INSTRUMENT CO. STORZ PREMIERE(R) MICROSURGICAL SYSTEM 03/22/1995
K950114 STORZ INSTRUMENT CO. STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM 06/02/1995
K926381 SURGEON DESIGN OCUSYSTEM IIE 12/06/1993
K954241 SURGEON SURGICAL INSTRUMENTATION, INC. SURGIN GENISIS PHACOEMULSIFIER 12/01/1995
K961243 SURGICAL DESIGN CORP. OCUSYSTEM ART ADVANTAGE 07/10/1996
K991852 SURGICAL DESIGN CORP. OCUSYSTEM ART ADVANTAGE, MODEL 995 07/07/1999
K942516 SURGIN SURGICAL INSTRUMENTATION, INC. 10-0 CASSETTE 07/25/1994
K942517 SURGIN SURGICAL INSTRUMENTATION, INC. 10-K CASSETTE 07/25/1994
K942518 SURGIN SURGICAL INSTRUMENTATION, INC. CASSETTE SYSTEM FOR SITE 07/25/1994
K942945 SURGIN SURGICAL INSTRUMENTATION, INC. CASSETTE SYSTEM FOR STORZ 12/05/1994
K943102 SURGIN SURGICAL INSTRUMENTATION, INC. HIGH PERFORMANCE TIPS 07/28/1994
K942515 SURGIN SURGICAL INSTRUMENTATION, INC. PHACO KIT 07/25/1994
K954238 SURGIN SURGICAL INSTRUMENTATION, INC. SURGIN GENISIS HANDPIECE 12/08/1995
K950600 SURGIN SURGICAL INSTRUMENTATION, INC. VACUUM SURGE SUPRESSER 05/10/1995
K923725 SYNERGETICS, INC. OPHTHALMIC PHARCO NEEDLE 03/18/1993
K002932 SYNTEC, INC. PHACOGARD 01/04/2001
K980480 SYNTEC, INC. SYNTEC VITMAN 05/04/1998
K830474 TEKNAR, INC. IV STAND 04/05/1983
K914229 TRI-STAR OPHTHALMIC PHACO TIP 12/27/1991
K953359 TRI-STAR OPHTHALMIC TRI-STAR UNIVERSAL I/A PHACO PAK 10/17/1995
K051186 TRILLIUM MEDICAL, INC. MICROPULSE PHACOEMULSIFICATION SYSTEM 08/18/2005
K834261 U-MOLDE SYSTEMS, INC. PLASTIC OPTICAL LENS M-110 03/16/1984
K954240 U.S. IOL, INC. EVOLUTION PHACOMULSIFIER 12/01/1995
K954746 U.S. IOL, INC. PHACO TIP 01/11/1996
K954239 U.S. IOL, INC. U.S. IOL PHACO HANDPIECE 12/08/1995
K850578 ULTRAMED, INC. PHACOEMULSIFICATION TIP 04/03/1985
K862021 ULTRAMED, INC. PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM 06/23/1986
K851209 UNITED SONICS, INC. CILCO/UNITED SONICS PHACE PF-9000 05/31/1985
K851298 UNITED SONICS, INC. MID LABS MVSXI 05/31/1985
K851211 UNITED SONICS, INC. PHACO PAK I 06/05/1985
K851212 UNITED SONICS, INC. UNITED SONICS PACO SYSTEM MODEL 3000 05/31/1985
K851210 UNITED SONICS, INC. UNITED SONICS PHACO MODULE, DF-35 05/31/1985
K870671 UNITED SURGICAL CORP. "PHACOTRON DAY PAK" 04/06/1987
K870806 UNITED SURGICAL CORP. NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 03/26/1987
K902150 UNITED SURGICAL CORP. PIEZO HANDPIECE 07/05/1990
K971064 VISION CARE DEVICES, INC. BAYERS BIMANUAL I/A HANDPIECES 06/09/1997
K843487 VISITEC CO. VISITEC OPHTHALMIC FLUID DISTRIB- SET 03/13/1985
K830385 VXTRA CORP. IRRIGATION/ASPIRATION KIT 04/05/1983
K830379 VXTRA CORP. PHAKO KIT 04/05/1983
K832980 VXTRA CORP. VXTRA OCUTOME KIT 10/19/1983
K971750 WELCH ALLYN, INC. WELCH ALLYN PHACO ILLUMINATOR 06/30/1997
K972063 WILLIAM F. WHITTINGHAM WHITTINGHAM ULTRACLEAN PHACO HANDPIECE 11/25/1997


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