HQC · Unit, Phacofragmentation
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | HQC |
|---|---|
| Device Name | Unit, Phacofragmentation |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Classification Rationale
Class II.
Cleared Devices (315)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Mar 25, 2026 | SESE |
| K250501 | System Sophi | This AG | Nov 14, 2025 | SESE |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 8, 2025 | SESE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | Jun 11, 2025 | SESE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | Jul 26, 2024 | SESE |
| K233398 | Faros Surgical System | Oertli Instrumente AG | Jun 27, 2024 | SESE |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | Jun 21, 2024 | SESE |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | Feb 26, 2024 | SESE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. | Jan 10, 2024 | SESE |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | Jul 31, 2023 | SESE |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Sep 9, 2022 | SESE |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 24, 2022 | SESE |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | Jun 14, 2022 | SESE |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | Apr 19, 2022 | SESE |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | Johnson & Johnson Surgical Vision, Inc. | Mar 12, 2021 | SESE |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Oct 15, 2020 | SESE |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Jul 31, 2020 | SESE |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | Jun 15, 2020 | SESE |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | May 27, 2020 | SESE |
| K191650 | LEGION System | Alcon Research, LLC | Nov 1, 2019 | SESE |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | D.O.R.C. Dutch Ophthalmic Research Center (International) | Sep 25, 2019 | SESE |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Johnson & Johnson Surgical Vision, Inc. | Aug 16, 2019 | SESE |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | Aug 13, 2019 | SESE |
| K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | Apr 19, 2017 | SESE |
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | Apr 14, 2017 | SESE |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | Mar 24, 2017 | SESE |
| K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | Apr 27, 2016 | SESE |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | Abbott Medical Optics, Inc. | Oct 19, 2015 | SESE |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | Sep 2, 2015 | SESE |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) | Dutch Ophthalmic Research Center International BV | Mar 13, 2015 | SESE |
| K133562 | CATARHEX 3 | Oertli Instrumente AG | Aug 12, 2014 | SESE |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb | Mar 12, 2014 | SESE |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | Abbott Medical Optics, Inc. | Feb 27, 2014 | SESE |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | Bausch & Lomb | Feb 14, 2014 | SESE |
| K121555 | CENTURION VISION SYSTEM | Alcon Laboratories, Inc. | Dec 21, 2012 | SESE |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | Lensar, Inc. | Dec 3, 2012 | SESE |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | Abbott Medical Optics, Inc. | Oct 15, 2012 | SESE |
| K120732 | LENSSX LASER SYSTEM | Alcon Lensx, Inc. | Sep 6, 2012 | SESE |
| K120912 | INFINITI(R) VISION SYSTEM | Alcon Manufacturing, Ltd. | Jun 15, 2012 | SESE |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | Dec 21, 2011 | SESE |
| K112425 | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE | Alcon Manufacturing, Ltd. | Nov 21, 2011 | SESE |
| K111882 | LAMINAR FLOW PHACO TIPS | Abbott Medical Optics, Inc. | Nov 7, 2011 | SESE |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | Sep 27, 2011 | SESE |
| K103023 | UNIT, PHACOFRAGMENTATION | Abbott Medical Optics, Inc. | Jun 1, 2011 | SESE |
| K101285 | CONSTELLATION VISION SYSTEM | Alcon Manufacturing, Ltd. | Nov 12, 2010 | SESE |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb, Inc. | Aug 17, 2010 | SESE |
| K093210 | AQUALASE CAPSULE WASH TIP | Alcon Manufacturing, Ltd. | Mar 4, 2010 | SESE |
| K091915 | FLUID ISOLATION DEVICE | Lenstec, Inc. | Oct 27, 2009 | SESE |
| K091777 | ALCON ULTRACHOPPER | Alcon Research, Ltd. | Oct 20, 2009 | SESE |
| K082845 | INFINITI VISION SYSTEM WITH OZIL IP | Alcon Research, Ltd. | Feb 12, 2009 | SESE |
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | Jan 5, 2009 | SESE |
| K081877 | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS | Dutch Ophthalmic Research Center International BV | Jan 5, 2009 | SESE |
| K080803 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 | American Optisurgical, Inc. | Sep 22, 2008 | SESE |
| K082132 | BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK | Bausch & Lomb, Inc. | Aug 28, 2008 | SESE |
| K063583 | ALCON VISION SYSTEM | Alcon | May 9, 2008 | SESE |
| K073023 | STERILS SINGLE-USE I/A HANDPIECES | Bausch & Lomb, Inc. | Mar 12, 2008 | SESE |
| K063331 | BAUSCH & LOMB NGX MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | Dec 19, 2006 | SESE |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | Advanced Medical Optics, Inc. | Apr 7, 2006 | SESE |
| K051186 | MICROPULSE PHACOEMULSIFICATION SYSTEM | Trillium Medical, Inc. | Aug 18, 2005 | SESE |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | Advanced Medical Optics, Inc. | Apr 5, 2005 | SESE |
| K041998 | PHACO CHOP NEEDLES | Bausch & Lomb, Inc. | Aug 16, 2004 | SESE |
| K033653 | VENTURI PHACO PACK | Bausch & Lomb, Inc. | Dec 17, 2003 | SESE |
| K030957 | PERFECT CAPSULE | Milvella Pty. , Ltd. | Aug 20, 2003 | SESE |
| K031404 | DIGNITY OPHTHALMIC SURGICAL SYSTEM | Phacor Inc., A Santen Company | May 22, 2003 | SESE |
| K022833 | BENJAMIN ENVOY PHACO HANDPIECE | Benjamin Biomedical, Inc. | Sep 9, 2002 | SESE |
| K020527 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 | American Optisurgical, Inc. | Jul 9, 2002 | SESE |
| K021566 | INFINITI | Alcon Laboratories, Inc. | Jul 2, 2002 | SESE |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | Staar Surgical Co. | May 16, 2002 | SESE |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Allergan, Inc. | Feb 13, 2001 | SESE |
| K003512 | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II | A.R.C. Laser AG | Feb 8, 2001 | SESE |
| K002932 | PHACOGARD | Syntec, Inc. | Jan 4, 2001 | SESE |
| K002031 | PHACOFRAGMENTATION SYSTEM MEGATRON | Asclepion-Meditec AG | Dec 27, 2000 | SESE |
| K002986 | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 | A.R.C. Laser AG | Nov 29, 2000 | SESE |
| K002812 | IRIS RETRACTING PHACOEMULSIFICATION SLEEVE | Michael Reynard, M.D. | Nov 8, 2000 | SESE |
| K991852 | OCUSYSTEM ART ADVANTAGE, MODEL 995 | Surgical Design Corp. | Jul 7, 1999 | SESE |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | Fibra Sonics, Inc. | Feb 16, 1999 | SESE |
| K981989 | THE WAVE DIGITAL PHACO SYSTEM | Circuit Tree | Aug 25, 1998 | SESE |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Alcon Laboratories | Jun 23, 1998 | SESE |
| K981109 | QUITETIP | Paradigm Medical Industries, Inc. | Jun 9, 1998 | SESE |
| K980480 | SYNTEC VITMAN | Syntec, Inc. | May 4, 1998 | SESE |
| K980085 | PHACO COMMANDER | Scieran Technologies, Inc. | Feb 24, 1998 | SESE |
| K974469 | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL | Mentor Corp. | Feb 24, 1998 | SESE |
| K974719 | PHACOPAK | Paradigm Medical Industries, Inc. | Jan 20, 1998 | SESE |
| K973749 | FRAG COMMANDER | Scieran Technologies, Inc. | Dec 8, 1997 | SESE |
| K972063 | WHITTINGHAM ULTRACLEAN PHACO HANDPIECE | William F. Whittingham | Nov 25, 1997 | SESE |
| K972253 | P3 UNIVERSAL PHACO HANDPIECE | Odyssey Technologies, Inc. | Jul 29, 1997 | SESE |
| K972252 | VISTA UNIVERSAL HANDPIECE | Odyssey Technologies, Inc. | Jul 29, 1997 | SESE |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Paradigm Medical Industries, Inc. | Jul 14, 1997 | SESE |
| K971750 | WELCH ALLYN PHACO ILLUMINATOR | Welch Allyn, Inc. | Jun 30, 1997 | SESE |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | Jun 17, 1997 | SESE |
| K971186 | AMO DIPLOMAX/OPSYS CONSOLE | Allergan, Inc. | Jun 13, 1997 | SESE |
| K971064 | BAYERS BIMANUAL I/A HANDPIECES | Visioncare Devices, Inc. | Jun 9, 1997 | SESE |
| K965127 | DGH MODEL 9000 | Dgh Technology, Inc. | Mar 17, 1997 | SESE |
| K964018 | PHACOILLUMINATOR - FIBEROPTIC SLEEVE | Michael Reynard, M.D. | Feb 26, 1997 | SESE |
| K960287 | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM | Nidek, Inc. | Nov 5, 1996 | SESE |
| K960811 | PHACOSCOPE | Saint John'S Plaza Medical Group | Oct 2, 1996 | SESE |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Storz Instrument Co. | Sep 20, 1996 | SESE |
| K962402 | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) | Allergan, Inc. | Sep 19, 1996 | SESE |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Storz Instrument Co. | Aug 29, 1996 | SESE |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Storz Instrument Co. | Aug 23, 1996 | SESE |
| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | Storz Instrument Co. | Aug 6, 1996 | SESE |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Storz Instrument Co. | Aug 6, 1996 | SESE |
| K961820 | STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK | Storz Instrument Co. | Jul 25, 1996 | SESE |
| K962431 | CTM DISPOSABLE PAK | Circuit Tree Medical, Inc. | Jul 23, 1996 | SESE |
| K962430 | CTM REUSABLE PAK | Circuit Tree Medical, Inc. | Jul 23, 1996 | SESE |
| K961658 | MEGATRON OPHTHALMIC SURGICAL SYSTEM | Intl. Ophthalmic Industries Corp. | Jul 23, 1996 | SESE |
| K961243 | OCUSYSTEM ART ADVANTAGE | Surgical Design Corp. | Jul 10, 1996 | SESE |
| K961310 | STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) | Storz Instrument Co. | Jun 27, 1996 | SESE |
| K960414 | SYNERGIST POWER PACK | Chiron Vision Corp. | Apr 24, 1996 | SESE |
| K955901 | STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX | Storz Instrument Co. | Mar 28, 1996 | SESE |
| K955789 | ALCON SERIES 20000 LEGACY MACKOOL SYSTEM | Alcon Laboratories | Mar 21, 1996 | SESE |
| K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | Mentor O & O, Inc. | Feb 12, 1996 | SESE |
| K954746 | PHACO TIP | U.S. Iol, Inc. | Jan 11, 1996 | SESE |
| K953539 | DM001 DISPOSABLE PACK | American Optisurgical, Inc. | Dec 26, 1995 | SESE |
| K953538 | RM001 REUSABLE | American Optisurgical, Inc. | Dec 26, 1995 | SESE |
| K954340 | STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE | Storz | Dec 14, 1995 | SESE |
| K954239 | U.S. IOL PHACO HANDPIECE | U.S. Iol, Inc. | Dec 8, 1995 | SESE |
| K954238 | SURGIN GENISIS HANDPIECE | Surgin Surgical Instrumentation, Inc. | Dec 8, 1995 | SESE |
| K954237 | CIRCUIT TREE PHACO HANDPIECE | Circuit Tree | Dec 8, 1995 | SESE |
| K954242 | CIRCUIT TREE PHACOEMULSIFIER | Circuit Tree | Dec 1, 1995 | SESE |
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | Surgeon Surgical Instrumentation, Inc. | Dec 1, 1995 | SESE |
| K954240 | EVOLUTION PHACOMULSIFIER | U.S. Iol, Inc. | Dec 1, 1995 | SESE |
| K953959 | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES | Microsurgical Technology, Inc. | Nov 17, 1995 | SESE |
| K951463 | STORZ I/A HANDPIECES | Storz Instrument Co. | Oct 27, 1995 | SESE |
| K953359 | TRI-STAR UNIVERSAL I/A PHACO PAK | Tri-Star Ophthalmic | Oct 17, 1995 | SESE |
| K953447 | PRECISIONIST THIRTY THOUSAND | Paradigm Medical Industries, Inc. | Oct 13, 1995 | SESE |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | Chiron Vision Corp. | Oct 12, 1995 | SESE |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | Chiron Vision Corp. | Oct 5, 1995 | SESE |
| K950881 | PHACO TIP | American Optical Corp. | Sep 6, 1995 | SESE |
| K952468 | HI-LINE MEDICAL PHACOEMULSIFIER TIP | Hi-Line Medical | Aug 24, 1995 | SESE |
| K952331 | AOI LC-40 PHACOEMULSIFIER | American Optisurgical, Inc. | Aug 16, 1995 | SESE |
| K952213 | ALCON SERIES 20000 LEGACY PHACOEMULSIFIER | Alcon Laboratories | Aug 9, 1995 | SESE |
| K953078 | STORZ DP4101 BASIC I/A PACK | Storz Instrument Co. | Aug 7, 1995 | SESE |
| K951824 | STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) | Nidek, Inc. | Jul 19, 1995 | SESE |
| K950218 | OMS SLIMLINE PHACO HANDPIECE | Optical Micro Systems, Inc. | Jul 17, 1995 | SESE |
| K946054 | DIPLOMAX | Optical Micro Systems, Inc. | Jul 11, 1995 | SESE |
| K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM | Allergan Medical Optics | Jun 15, 1995 | SESE |
| K952259 | STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | Jun 14, 1995 | SESE |
| K950114 | STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM | Storz Instrument Co. | Jun 2, 1995 | SESE |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | American Optical Corp. | May 26, 1995 | SESE |
| K950800 | PRO-PAK FOR OMS DIPLOMATE | M. Imonti and Associates Inc., | May 22, 1995 | SESE |
| K950798 | POSTERIOR CAPSULE SHIELD | Oasis Medical, Inc. | May 22, 1995 | SESE |
| K950600 | VACUUM SURGE SUPRESSER | Surgin Surgical Instrumentation, Inc. | May 10, 1995 | SESE |
| K946227 | STORZ PREMIERE(R) MICROSURGICAL SYSTEM | Storz Instrument Co. | Mar 22, 1995 | SESE |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | Chiron Vision Corp. | Mar 14, 1995 | SESE |
| K946176 | STORZ PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | Feb 14, 1995 | SESE |
| K945583 | OCUSYSTEM(ART) | Arent Fox | Feb 13, 1995 | SESE |
| K942945 | CASSETTE SYSTEM FOR STORZ | Surgin Surgical Instrumentation, Inc. | Dec 5, 1994 | SESE |
| K935926 | STORZ PHACO AND FRAG HANDPIECES | Storz Instrument Co. | Nov 28, 1994 | SESE |
| K943672 | PHACO NEEDLES AND TIPS | Microsurgical Technology, Inc. | Oct 13, 1994 | SESE |
| K943379 | PHACO TIPS FOR PHACO FRAGMENTATION MACHINES | Oasis Medical, Inc. | Oct 11, 1994 | SESE |
| K940083 | STANDARD PHACO TIP 15, 30, 45, 60 | Medical Technical Products | Sep 28, 1994 | SESE |
| K940088 | MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE | Medical Technical Products | Aug 4, 1994 | SESE |
| K943102 | HIGH PERFORMANCE TIPS | Surgin Surgical Instrumentation, Inc. | Jul 28, 1994 | SESE |
| K942518 | CASSETTE SYSTEM FOR SITE | Surgin Surgical Instrumentation, Inc. | Jul 25, 1994 | SESE |
| K942517 | 10-K CASSETTE | Surgin Surgical Instrumentation, Inc. | Jul 25, 1994 | SESE |
| K942516 | 10-0 CASSETTE | Surgin Surgical Instrumentation, Inc. | Jul 25, 1994 | SESE |
| K942515 | PHACO KIT | Surgin Surgical Instrumentation, Inc. | Jul 25, 1994 | SESE |
| K940084 | MODEL 2000 OPHTHALMIC SURGICAL SYSTEM | Medical Technical Products | Jun 17, 1994 | SESE |
| K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES | O.R. Specialties, Inc. | Apr 6, 1994 | SESE |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | Optical Micro Systems, Inc. | Mar 14, 1994 | SESE |
| K931358 | AORP4000 REUSABLE PAK | American Optical Corp. | Feb 22, 1994 | SESE |
| K931354 | P4000 PHACOEMULSIFIER | American Optical Corp. | Feb 22, 1994 | SESE |
| K925828 | MODIFIED SITE TXR SYSTEMS | Site Microsurgical Systems, Inc. | Feb 16, 1994 | SESE |
| K933627 | PHACOFRAGMENTOR TIP | M. Imonti and Associates Inc., | Jan 25, 1994 | SESE |
| K931357 | AOD4000 DISPOSABLE PAK | American Optical Corp. | Jan 25, 1994 | SESE |
| K933503 | PRO-PHACO HANDPIECE | M. Imonti and Associates Inc., | Jan 6, 1994 | SESE |
| K926381 | OCUSYSTEM IIE | Surgeon Design | Dec 6, 1993 | SESE |
| K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE | Site Microsurgical Systems, Inc. | Nov 12, 1993 | SESE |
| K926512 | STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE | Storz | Sep 9, 1993 | SESE |
| K925631 | PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE | Chiron Intraoptics | Jul 29, 1993 | SESE |
| K924260 | NIDEK CV-12000 | Nidek, Inc. | Mar 26, 1993 | SESE |
| K923725 | OPHTHALMIC PHARCO NEEDLE | Synergetics, Inc. | Mar 18, 1993 | SESE |
| K925254 | AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 | Allergan Medical Optics | Jan 7, 1993 | SESE |
| K924235 | AMO ELITE | Allergan Medical Optics | Dec 23, 1992 | SESE |
| K924033 | ALTEX MODEL UST-3000E | Optro-Mechanics (Usa) Corp. | Nov 5, 1992 | SESE |
| K922595 | MODIFIED SITE MACROBORE PHACO NEEDLE | Chiron Vision Corp. | Aug 31, 1992 | SESE |
| K921607 | IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE | Chiron Vision Corp. | Jun 30, 1992 | SESE |
| K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM | Mentor O & O, Inc. | Jun 11, 1992 | SESE |
| K921135 | IOLAB POWER I.V. POLE | Site Microsurgical Systems, Inc. | Jun 3, 1992 | SESE |
| K915457 | PHACO 20/20 SYSTEM I | Innovative Medical Systems, Inc. | Feb 24, 1992 | SESE |
| K915456 | PHACO 3000 LINEAR | Innovative Medical Systems, Inc. | Feb 12, 1992 | SESE |
| K915118 | PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE | Ipax, Inc. | Dec 27, 1991 | SESE |
| K914229 | PHACO TIP | Tri-Star Ophthalmic | Dec 27, 1991 | SESE |
| K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | Dec 17, 1991 | SESE |
| K914172 | KPE 230 AM | Ipax, Inc. | Oct 25, 1991 | SESE |
| K913530 | LOOK VISCODISSECTOR | Look, Inc. | Oct 21, 1991 | SESE |
| K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE | Site Microsurgical Systems, Inc. | Aug 28, 1991 | SESE |
| K911808 | GEMINI OPHTHALMIC SURGERY SYSTEM | Alcon Laboratories | Jun 25, 1991 | SESE |
| K904612 | I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) | Medical Technical Products | Dec 26, 1990 | SESE |
| K904183 | SITE PHACOEMULSIFICATION HANDPIECE | Site Microsurgical Systems, Inc. | Dec 5, 1990 | SESE |
| K904151 | SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE | Site Microsurgical Systems, Inc. | Dec 5, 1990 | SESE |
| K902876 | PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI. | Intraoptics Surgical, Inc. | Sep 18, 1990 | SESE |
| K902798 | AUTOMATED HYDROSONICS(TM) | Alcon Surgical, Inc. | Aug 28, 1990 | SESE |
| K900493 | THE PRECISIONIST | Paradigm Medical, Inc. | Aug 28, 1990 | SESE |
| K902150 | PIEZO HANDPIECE | United Surgical Corp. | Jul 5, 1990 | SESE |
| K901686 | NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 | Nidek, Inc. | Jun 8, 1990 | SESE |
| K894512 | PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS | Intl. Ophthalmic Industries Corp. | Oct 17, 1989 | SESE |
| K894511 | MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT | Intl. Ophthalmic Industries Corp. | Oct 17, 1989 | SESE |
| K892852 | SITE PHACO PLUS INFUSION SLEEVE | Site Microsurgical Systems, Inc. | Jun 8, 1989 | SESE |
Top Applicants
- Storz Instrument Co. — 17 clearances
- CooperVision, Inc. — 15 clearances
- Chiron Vision Corp. — 15 clearances
- Site Microsurgical Systems, Inc. — 14 clearances
- Abbott Medical Optics, Inc. — 9 clearances
