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 |
| K063583 | ALCON | ALCON VISION SYSTEM | 05/09/2008 |
| K955789 | ALCON LABORATORIES | ALCON SERIES 20000 LEGACY MACKOOL SYSTEM | 03/21/1996 |
| 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 |
| K191650 | Alcon Research, LLC | LEGION System | 11/01/2019 |
| 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 |
| 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 |
| K020527 | AMERICAN OPTISURGICAL, INC. | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 | 07/09/2002 |
| K080803 | AMERICAN OPTISURGICAL, INC. | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 | 09/22/2008 |
| K002031 | ASCLEPION-MEDITEC AG | PHACOFRAGMENTATION SYSTEM MEGATRON | 12/27/2000 |
| 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 |
| K022833 | BENJAMIN BIOMEDICAL, INC. | BENJAMIN ENVOY PHACO HANDPIECE | 09/09/2002 |
| K212241 | Carl Zeiss Meditec AG | QUATERA 700 | 04/19/2022 |
| K230858 | Carl Zeiss Meditec AG | QUATERA 700 | 07/31/2023 |
| K193376 | Carl Zeiss Meditec AG | Visalis V500, Visalis S500 | 06/15/2020 |
| K200584 | Carl Zeiss Meditec Cataract Technology Inc | xPORT 304 (miCOR) System Lens Fragmentation System | 07/31/2020 |
| K214028 | Carl Zeiss Meditec Cataract Technology Inc. | MICOR Lens Fragmentation System | 09/09/2022 |
| K222236 | Carl Zeiss Meditec Cataract Technology Inc. | miCOR System Lens Fragmentation System | 08/24/2022 |
| K191024 | Carl Zeiss Meditec Cataract Technology Inc. | xPORT Lens Fragmentation System | 08/13/2019 |
| K200207 | Carl Zeiss Meditec Cataract Technology Inc. | xPORT S Lens Fragmentation System | 10/15/2020 |
| K960414 | CHIRON VISION CORP. | SYNERGIST POWER PACK | 04/24/1996 |
| 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 |
| K213467 | D.O.R.C. Dutch Ophthalmic Research Center (International) | EVA NEXUS Ophthalmic Surgical System | 06/14/2022 |
| K190875 | D.O.R.C. Dutch Ophthalmic Research Center (International) | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | 09/25/2019 |
| K965127 | DGH TECHNOLOGY, INC. | DGH MODEL 9000 | 03/17/1997 |
| 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 |
| K984143 | FIBRA SONICS, INC. | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | 02/16/1999 |
| K961658 | INTL. OPHTHALMIC INDUSTRIES CORP. | MEGATRON OPHTHALMIC SURGICAL SYSTEM | 07/23/1996 |
| K191933 | Johnson & Johnson Surgical Vision, Inc. | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | 08/16/2019 |
| K203060 | Johnson & Johnson Surgical Vision, Inc. | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | 03/12/2021 |
| K122829 | LENSAR, INC. | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | 12/03/2012 |
| K091915 | LENSTEC, INC. | FLUID ISOLATION DEVICE | 10/27/2009 |
| K974469 | MENTOR CORP. | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL | 02/24/1998 |
| K955245 | MENTOR O & O, INC. | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | 02/12/1996 |
| K002812 | MICHAEL REYNARD, M.D. | IRIS RETRACTING PHACOEMULSIFICATION SLEEVE | 11/08/2000 |
| K964018 | MICHAEL REYNARD, M.D. | PHACOILLUMINATOR - FIBEROPTIC SLEEVE | 02/26/1997 |
| K030957 | MILVELLA PTY. LTD. | PERFECT CAPSULE | 08/20/2003 |
| K960287 | NIDEK, INC. | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM | 11/05/1996 |
| 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 |
| K971795 | PARADIGM MEDICAL INDUSTRIES, INC. | AUTOMATED CHAMBER MAINTENANCE MODULE | 07/14/1997 |
| K974719 | PARADIGM MEDICAL INDUSTRIES, INC. | PHACOPAK | 01/20/1998 |
| K981109 | PARADIGM MEDICAL INDUSTRIES, INC. | QUITETIP | 06/09/1998 |
| K031404 | PHACOR INC., A SANTEN COMPANY | DIGNITY OPHTHALMIC SURGICAL SYSTEM | 05/22/2003 |
| K192418 | Raico LLC | Phacoemulsification Needle (Tip) and Irrigation Sleeve | 05/27/2020 |
| 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 |
| K020734 | STAAR SURGICAL CO. | SURGE-FREE ASPIRATION ADAPTER | 05/16/2002 |
| 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 |
| 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 |
| K971439 | STORZ INSTRUMENT CO. | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | 06/17/1997 |
| K961243 | SURGICAL DESIGN CORP. | OCUSYSTEM ART ADVANTAGE | 07/10/1996 |
| K991852 | SURGICAL DESIGN CORP. | OCUSYSTEM ART ADVANTAGE, MODEL 995 | 07/07/1999 |
| K002932 | SYNTEC, INC. | PHACOGARD | 01/04/2001 |
| K980480 | SYNTEC, INC. | SYNTEC VITMAN | 05/04/1998 |
| K051186 | TRILLIUM MEDICAL, INC. | MICROPULSE PHACOEMULSIFICATION SYSTEM | 08/18/2005 |
| K954746 | U.S. IOL, INC. | PHACO TIP | 01/11/1996 |
| K971064 | VISION CARE DEVICES, INC. | BAYERS BIMANUAL I/A HANDPIECES | 06/09/1997 |
| 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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