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Unit, Phacofragmentation

FDA product code HQC · 309 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.4670
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-09-26 – 2026-05-15

HQC 1996-07-10

OCUSYSTEM ART ADVANTAGE

Applicant Surgical Design Corp.

K number K961243

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HQC 1996-06-27

STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)

Applicant Storz Instrument Co.

K number K961310

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HQC 1996-04-24

SYNERGIST POWER PACK

Applicant Chiron Vision Corp.

K number K960414

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HQC 1996-03-28

STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX

Applicant Storz Instrument Co.

K number K955901

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HQC 1996-03-21

ALCON SERIES 20000 LEGACY MACKOOL SYSTEM

Applicant Alcon Laboratories

K number K955789

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HQC 1996-02-12

MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM

Applicant Mentor O & O, Inc.

K number K955245

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HQC 1996-01-11

PHACO TIP

Applicant U.S. Iol, Inc.

K number K954746

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HQC 1995-12-26

DM001 DISPOSABLE PACK

Applicant American Optisurgical, Inc.

K number K953539

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HQC 1995-12-26

RM001 REUSABLE

Applicant American Optisurgical, Inc.

K number K953538

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HQC 1995-12-14

STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE

Applicant Storz

K number K954340

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HQC 1995-12-08

U.S. IOL PHACO HANDPIECE

Applicant U.S. Iol, Inc.

K number K954239

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HQC 1995-12-08

SURGIN GENISIS HANDPIECE

Applicant Surgin Surgical Instrumentation, Inc.

K number K954238

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HQC 1995-12-08

CIRCUIT TREE PHACO HANDPIECE

Applicant Circuit Tree

K number K954237

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HQC 1995-12-01

CIRCUIT TREE PHACOEMULSIFIER

Applicant Circuit Tree

K number K954242

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HQC 1995-12-01

SURGIN GENISIS PHACOEMULSIFIER

Applicant Surgeon Surgical Instrumentation, Inc.

K number K954241

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HQC 1995-12-01

EVOLUTION PHACOMULSIFIER

Applicant U.S. Iol, Inc.

K number K954240

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HQC 1995-11-17

PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES

Applicant Microsurgical Technology, Inc.

K number K953959

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HQC 1995-10-27

STORZ I/A HANDPIECES

Applicant Storz Instrument Co.

K number K951463

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HQC 1995-10-17

TRI-STAR UNIVERSAL I/A PHACO PAK

Applicant Tri-Star Ophthalmic

K number K953359

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HQC 1995-10-13

PRECISIONIST THIRTY THOUSAND

Applicant Paradigm Medical Industries, Inc.

K number K953447

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HQC 1995-10-12

IOLAB.SITE CD PHACOEMULSIFICATION MODULE

Applicant Chiron Vision Corp.

K number K944993

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HQC 1995-10-05

IOLAB/SITE PERISTALTIC MODULE

Applicant Chiron Vision Corp.

K number K944995

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HQC 1995-09-06

PHACO TIP

Applicant American Optical Corp.

K number K950881

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HQC 1995-08-24

HI-LINE MEDICAL PHACOEMULSIFIER TIP

Applicant Hi-Line Medical

K number K952468

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HQC 1995-08-16

AOI LC-40 PHACOEMULSIFIER

Applicant American Optisurgical, Inc.

K number K952331

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HQC 1995-08-09

ALCON SERIES 20000 LEGACY PHACOEMULSIFIER

Applicant Alcon Laboratories

K number K952213

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HQC 1995-08-07

STORZ DP4101 BASIC I/A PACK

Applicant Storz Instrument Co.

K number K953078

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HQC 1995-07-19

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)

Applicant Nidek, Inc.

K number K951824

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HQC 1995-07-17

OMS SLIMLINE PHACO HANDPIECE

Applicant Optical Micro Systems, Inc.

K number K950218

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HQC 1995-07-11

DIPLOMAX

Applicant Optical Micro Systems, Inc.

K number K946054

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HQC 1995-06-15

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM

Applicant Allergan Medical Optics

K number K951462

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HQC 1995-06-14

STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES

Applicant Storz Instrument Co.

K number K952259

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HQC 1995-06-02

STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM

Applicant Storz Instrument Co.

K number K950114

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HQC 1995-05-26

AOI UNIVERSAL ULTRASONIC HANDPIECE

Applicant American Optical Corp.

K number K950880

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HQC 1995-05-22

PRO-PAK FOR OMS DIPLOMATE

Applicant M. Imonti and Associates Inc.,

K number K950800

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HQC 1995-05-22

POSTERIOR CAPSULE SHIELD

Applicant Oasis Medical, Inc.

K number K950798

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HQC 1995-05-10

VACUUM SURGE SUPRESSER

Applicant Surgin Surgical Instrumentation, Inc.

K number K950600

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HQC 1995-03-22

STORZ PREMIERE(R) MICROSURGICAL SYSTEM

Applicant Storz Instrument Co.

K number K946227

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HQC 1995-03-14

IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE

Applicant Chiron Vision Corp.

K number K944994

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HQC 1995-02-14

STORZ PHACOEMULSIFICATION NEEDLES

Applicant Storz Instrument Co.

K number K946176

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HQC 1995-02-13

OCUSYSTEM(ART)

Applicant Arent Fox

K number K945583

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HQC 1994-12-05

CASSETTE SYSTEM FOR STORZ

Applicant Surgin Surgical Instrumentation, Inc.

K number K942945

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HQC 1994-11-28

STORZ PHACO AND FRAG HANDPIECES

Applicant Storz Instrument Co.

K number K935926

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HQC 1994-10-13

PHACO NEEDLES AND TIPS

Applicant Microsurgical Technology, Inc.

K number K943672

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HQC 1994-10-11

PHACO TIPS FOR PHACO FRAGMENTATION MACHINES

Applicant Oasis Medical, Inc.

K number K943379

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HQC 1994-09-28

STANDARD PHACO TIP 15, 30, 45, 60

Applicant Medical Technical Products

K number K940083

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HQC 1994-08-04

MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE

Applicant Medical Technical Products

K number K940088

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HQC 1994-07-28

HIGH PERFORMANCE TIPS

Applicant Surgin Surgical Instrumentation, Inc.

K number K943102

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HQC 1994-07-25

CASSETTE SYSTEM FOR SITE

Applicant Surgin Surgical Instrumentation, Inc.

K number K942518

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HQC 1994-07-25

10-K CASSETTE

Applicant Surgin Surgical Instrumentation, Inc.

K number K942517

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HQC 1994-07-25

10-0 CASSETTE

Applicant Surgin Surgical Instrumentation, Inc.

K number K942516

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HQC 1994-07-25

PHACO KIT

Applicant Surgin Surgical Instrumentation, Inc.

K number K942515

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HQC 1994-06-17

MODEL 2000 OPHTHALMIC SURGICAL SYSTEM

Applicant Medical Technical Products

K number K940084

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HQC 1994-04-06

PHACO NEEDLES 1000-R & 1000-O NEEDLES

Applicant O.R. Specialties, Inc.

K number K923630

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HQC 1994-03-14

OPHTHALMIC SURGICAL SYSTEM

Applicant Optical Micro Systems, Inc.

K number K935223

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HQC 1994-02-22

AORP4000 REUSABLE PAK

Applicant American Optical Corp.

K number K931358

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HQC 1994-02-22

P4000 PHACOEMULSIFIER

Applicant American Optical Corp.

K number K931354

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HQC 1994-02-16

MODIFIED SITE TXR SYSTEMS

Applicant Site Microsurgical Systems, Inc.

K number K925828

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HQC 1994-01-25

PHACOFRAGMENTOR TIP

Applicant M. Imonti and Associates Inc.,

K number K933627

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HQC 1994-01-25

AOD4000 DISPOSABLE PAK

Applicant American Optical Corp.

K number K931357

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HQC 1994-01-06

PRO-PHACO HANDPIECE

Applicant M. Imonti and Associates Inc.,

K number K933503

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HQC 1993-12-06

OCUSYSTEM IIE

Applicant Surgeon Design

K number K926381

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HQC 1993-11-12

SITE'S CD II PHACOEMULSIFICATION HANDPIECE

Applicant Site Microsurgical Systems, Inc.

K number K931866

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HQC 1993-09-09

STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE

Applicant Storz

K number K926512

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HQC 1993-07-29

PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE

Applicant Chiron Intraoptics

K number K925631

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HQC 1993-03-26

NIDEK CV-12000

Applicant Nidek, Inc.

K number K924260

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HQC 1993-03-18

OPHTHALMIC PHARCO NEEDLE

Applicant Synergetics, Inc.

K number K923725

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HQC 1993-01-07

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

Applicant Allergan Medical Optics

K number K925254

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HQC 1992-12-23

AMO ELITE

Applicant Allergan Medical Optics

K number K924235

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HQC 1992-11-05

ALTEX MODEL UST-3000E

Applicant Optro-Mechanics (Usa) Corp.

K number K924033

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HQC 1992-08-31

MODIFIED SITE MACROBORE PHACO NEEDLE

Applicant Chiron Vision Corp.

K number K922595

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HQC 1992-06-30

IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE

Applicant Chiron Vision Corp.

K number K921607

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HQC 1992-06-11

MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

Applicant Mentor O & O, Inc.

K number K912904

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HQC 1992-06-03

IOLAB POWER I.V. POLE

Applicant Site Microsurgical Systems, Inc.

K number K921135

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HQC 1992-02-24

PHACO 20/20 SYSTEM I

Applicant Innovative Medical Systems, Inc.

K number K915457

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HQC 1992-02-12

PHACO 3000 LINEAR

Applicant Innovative Medical Systems, Inc.

K number K915456

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HQC 1991-12-27

PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE

Applicant Ipax, Inc.

K number K915118

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HQC 1991-12-27

PHACO TIP

Applicant Tri-Star Ophthalmic

K number K914229

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HQC 1991-12-17

PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

Applicant Site Microsurgical Systems, Inc.

K number K912902

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HQC 1991-10-25

KPE 230 AM

Applicant Ipax, Inc.

K number K914172

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HQC 1991-10-21

LOOK VISCODISSECTOR

Applicant Look, Inc.

K number K913530

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HQC 1991-08-28

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE

Applicant Site Microsurgical Systems, Inc.

K number K912739

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HQC 1991-06-25

GEMINI OPHTHALMIC SURGERY SYSTEM

Applicant Alcon Laboratories

K number K911808

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HQC 1990-12-26

I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)

Applicant Medical Technical Products

K number K904612

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HQC 1990-12-05

SITE PHACOEMULSIFICATION HANDPIECE

Applicant Site Microsurgical Systems, Inc.

K number K904183

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HQC 1990-12-05

SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE

Applicant Site Microsurgical Systems, Inc.

K number K904151

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HQC 1990-09-18

PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.

Applicant Intraoptics Surgical, Inc.

K number K902876

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HQC 1990-08-28

AUTOMATED HYDROSONICS(TM)

Applicant Alcon Surgical, Inc.

K number K902798

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HQC 1990-08-28

THE PRECISIONIST

Applicant Paradigm Medical, Inc.

K number K900493

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HQC 1990-07-05

PIEZO HANDPIECE

Applicant United Surgical Corp.

K number K902150

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HQC 1990-06-08

NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000

Applicant Nidek, Inc.

K number K901686

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HQC 1989-10-17

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

Applicant Intl. Ophthalmic Industries Corp.

K number K894512

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HQC 1989-10-17

MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT

Applicant Intl. Ophthalmic Industries Corp.

K number K894511

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HQC 1989-06-08

SITE PHACO PLUS INFUSION SLEEVE

Applicant Site Microsurgical Systems, Inc.

K number K892852

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HQC 1989-05-26

VITRECTOMY PACK #J120

Applicant O.R. Specialties, Inc.

K number K891161

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HQC 1989-05-26

JUMPER PACK #203

Applicant O.R. Specialties, Inc.

K number K890825

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HQC 1989-05-17

SITE PERISTALTIC CASSETTE

Applicant Site Microsurgical Systems, Inc.

K number K892911

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HQC 1989-05-09

CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.

Applicant CooperVision, Inc.

K number K890635

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HQC 1989-04-06

PHACOEMULSIFIER MODEL 100

Applicant Sonic Needle Corp.

K number K890080

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HQC 1989-02-17

STAAR PHACO XL SMALL INCISION SYSTEM

Applicant Staar Surgical Co.

K number K884241

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