Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 1988-12-06

GV3000 PHACOEMULSIFIER/FRAGMENTER

Applicant D.O.R.C. Intl. B.V.

K number K883097

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HQC 1988-09-15

MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM

Applicant Chiron Vision Corp.

K number K883199

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HQC 1988-09-15

SITE MACROBORE PHACO NEEDLE

Applicant Site Microsurgical Systems, Inc.

K number K883099

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HQC 1988-07-01

SITE ULTRASONIC I/A PHACO NEEDLE

Applicant Site Microsurgical Systems, Inc.

K number K882103

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HQC 1988-07-01

NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM

Applicant Noetix, Inc.

K number K881635

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HQC 1988-03-07

C-MATE #CMU 1001

Applicant O.R. Specialties, Inc.

K number K880062

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HQC 1988-01-11

SOLOS SINGLE USE TITANIUM TIP

Applicant Solos Ophthalmology

K number K874334

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HQC 1987-08-10

SOLOS EYESITE CAP SLEEVE

Applicant Solos Ophthalmology

K number K872611

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HQC 1987-08-10

PART #860065 IA PAK & PART #860060 IA PAK

Applicant Medical Technical Products

K number K871473

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HQC 1987-07-27

FRIGITRONICS ACC-1000 CAPSULE CUTTER

Applicant Frigitronics of Connecticut, Inc.

K number K872362

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HQC 1987-07-27

IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS

Applicant CooperVision, Inc.

K number K871854

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HQC 1987-06-03

SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE

Applicant Site Microsurgical Systems, Inc.

K number K871485

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HQC 1987-05-29

CLASSIC 70 LENS

Applicant Korea Asahi Optical Co., Ltd.

K number K871649

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HQC 1987-04-06

PHACOTRON DAY PAK

Applicant United Surgical Corp.

K number K870671

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HQC 1987-03-26

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

Applicant United Surgical Corp.

K number K870806

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HQC 1987-01-20

I/A/KPE TIP

Applicant Ipax, Inc.

K number K864726

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HQC 1986-12-15

SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)

Applicant Site Microsurgical Systems, Inc.

K number K864301

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HQC 1986-10-31

GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT

Applicant Grieshaber & Co.

K number K864056

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HQC 1986-10-31

GRIESHABER GLOBAL CONTROL TUBING SET

Applicant Grieshaber & Co.

K number K863444

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HQC 1986-10-10

OPHTHALMIC FITLER MICRO CAPSULE

Applicant Ipax, Inc.

K number K863729

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HQC 1986-09-08

US PLUS-PAK(R) SURGICAL SYSTEM

Applicant Ipax, Inc.

K number K863209

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HQC 1986-08-11

MODEL A-8000 ULTRASONIC HANDPIECE CORD

Applicant Advanced Medical Technology, Inc.

K number K862777

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HQC 1986-06-23

PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM

Applicant Ultramed, Inc.

K number K862021

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HQC 1986-06-19

ENTRAVISION EP-500 I/A ECCO PACK

Applicant Entravision, Inc.

K number K862064

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HQC 1986-06-19

ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE

Applicant Entravision, Inc.

K number K862063

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HQC 1986-06-02

DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.

Applicant Medical Corp. of America

K number K860957

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HQC 1986-06-02

KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.

Applicant Medical Corp. of America

K number K860956

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HQC 1986-05-06

SITE PHACO DISPOSABLE CASSETTE

Applicant Site Microsurgical Systems, Inc.

K number K861060

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HQC 1986-05-06

SITE DISPOSABLE CASSETTE

Applicant Microsurgical Systems, Inc.

K number K860989

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HQC 1986-04-21

AM-100 I/A AMPAC

Applicant Dravon Medical, Inc.

K number K860770

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HQC 1985-12-27

COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR

Applicant CooperVision, Inc.

K number K854375

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HQC 1985-12-27

ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS

Applicant Advanced Medical Technology, Inc.

K number K854225

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HQC 1985-12-27

PHACO PACKS, 1A PACKS & PACK COMPONENTS

Applicant Medical Corp. of America

K number K854116

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HQC 1985-12-19

O.M.S. ULTRA-PHACO

Applicant Optical Micro Systems, Inc.

K number K844373

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HQC 1985-10-08

TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR

Applicant Medical Corp. of America

K number K853883

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HQC 1985-09-24

CREAT BRAND I/A PACK CREAT BRAND PHACO PACK

Applicant Aesthetech Corp.

K number K853189

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HQC 1985-08-20

COOPER VISION SYSTEM VI U/S MODULE

Applicant CooperVision, Inc.

K number K853070

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HQC 1985-08-20

PHACO-BAC STOP FILTER KIT

Applicant Staar Surgical Co.

K number K852208

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HQC 1985-08-05

PHAKOSYSTEMS MODEL CES 4100

Applicant Phakosystems, Inc.

K number K851674

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HQC 1985-06-05

PHACO PAK I

Applicant United Sonics, Inc.

K number K851211

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HQC 1985-05-31

MID LABS MVSXI

Applicant United Sonics, Inc.

K number K851298

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HQC 1985-05-31

UNITED SONICS PACO SYSTEM MODEL 3000

Applicant United Sonics, Inc.

K number K851212

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HQC 1985-05-31

UNITED SONICS PHACO MODULE, DF-35

Applicant United Sonics, Inc.

K number K851210

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HQC 1985-05-31

CILCO/UNITED SONICS PHACE PF-9000

Applicant United Sonics, Inc.

K number K851209

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HQC 1985-05-09

IOCARE CONVERTER KIT

Applicant Chiron Vision Corp.

K number K843276

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HQC 1985-04-15

ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK

Applicant Atlantic Optical Systems, Inc.

K number K850532

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HQC 1985-04-15

KCP PAK #2 CONVENIENCE PACK MODIFICATION

Applicant CooperVision, Inc.

K number K850275

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HQC 1985-04-15

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

Applicant CooperVision, Inc.

K number K850149

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HQC 1985-04-15

KCP PAK CONVENIENCE PACK

Applicant CooperVision, Inc.

K number K850148

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HQC 1985-04-03

INFUSION SLEEVE - OPHTHALMIC

Applicant Medical Instrument Development Laboratories, Inc.

K number K851009

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HQC 1985-04-03

PHACOEMULSIFICATION TIP

Applicant Ultramed, Inc.

K number K850578

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HQC 1985-03-29

PHACO-BAC STOP KIT

Applicant Staar Surgical Co.

K number K850900

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HQC 1985-03-29

I/A BAC STOP KIT

Applicant Staar Surgical Co.

K number K850899

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HQC 1985-03-13

VISITEC OPHTHALMIC FLUID DISTRIB- SET

Applicant Visitec Co.

K number K843487

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HQC 1985-02-14

CILCO I/A SURGICAL PACK

Applicant Cilco, Inc.

K number K843319

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HQC 1984-12-27

SITE ULTRASONIC EMULSIFICATION MODULE OP

Applicant Chiron Vision Corp.

K number K844666

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HQC 1984-12-11

MEDICAL OPTICS PHACOEMULSIFICATION KIT

Applicant American Medical Optics

K number K844150

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HQC 1984-12-11

COOPERVISION SYSTEM VI

Applicant CooperVision, Inc.

K number K842945

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HQC 1984-11-27

MENDEZ U/S CYSTOTOME

Applicant CooperVision, Inc.

K number K843386

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HQC 1984-11-27

IOCARE ULTRASONIC TITANIUM TIPS

Applicant Chiron Vision Corp.

K number K843278

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HQC 1984-11-27

IOCARE PHACOEMULSIFICATION PACK

Applicant Chiron Vision Corp.

K number K843277

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HQC 1984-11-27

IOCARE IRRIGATION/ASPIRATION PACK

Applicant Chiron Vision Corp.

K number K843275

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HQC 1984-11-27

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA

Applicant CooperVision, Inc.

K number K842979

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HQC 1984-10-05

CATAREX/ULTRASONICS KIT

Applicant Calliope Corp.

K number K840181

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HQC 1984-10-05

CATAREX VITRECUTTER I/A DISPOS. CUT

Applicant Calliope Corp.

K number K840063

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HQC 1984-08-15

SITE SIMCOE STYLE I/A HANDPIECE

Applicant Chiron Vision Corp.

K number K842458

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HQC 1984-06-19

MANUAL IRRIGATING/ASPIRATING UNIT

Applicant Alltek, Inc.

K number K840495

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HQC 1984-05-22

PHACOEMULSIFICATION KITS

Applicant Innovative Surgical Products, Inc.

K number K840695

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HQC 1984-05-09

SITE COAXIAL I/A HANDPIECE 30 TIP

Applicant Chiron Vision Corp.

K number K840965

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HQC 1984-04-05

IOCARE IRRIGATION & ASPIRATION PACK

Applicant Chiron Vision Corp.

K number K834340

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HQC 1984-03-29

IRRIGATION, ASPIRATION TUBING SETS

Applicant Innovative Surgical Products, Inc.

K number K841072

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HQC 1984-03-16

OCUCARE ULTRASOUND TIP & FREEDOM PACK

Applicant Intermedics Intraocular, Inc.

K number K834543

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HQC 1984-03-16

MICRO VIT FRAGMENTATION SYSTEM

Applicant Medical Instrument Development Laboratories, Inc.

K number K834537

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HQC 1984-03-16

PHACO FRAGMENTOR GT-1

Applicant Fibra Sonics, Inc.

K number K834453

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HQC 1984-03-16

PLASTIC OPTICAL LENS M-110

Applicant U-Molde Systems, Inc.

K number K834261

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HQC 1984-03-15

DISPOSABLE FIBER OPTIC ILLUMINATOR

Applicant CooperVision, Inc.

K number K833465

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HQC 1984-03-12

KPE PLUS-PAK SURGICAL SYSTEM

Applicant Ipax, Inc.

K number K833962

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HQC 1984-03-12

I/A PLUS PAK SURGICAL SYSTEM

Applicant Ipax, Inc.

K number K833961

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HQC 1984-03-05

DISPOS. I/A & IRRIGATION HANDPIECES

Applicant CooperVision, Inc.

K number K833783

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HQC 1984-03-05

PHAKO SYSTEMS VIA 2000

Applicant Pharosystems, Inc.

K number K833642

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HQC 1984-02-21

DISPOSABLE I/A HANDPIECE

Applicant CooperVision, Inc.

K number K833784

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HQC 1984-01-06

IRRIGATION ASPIRATION KIT

Applicant American Medical Optics

K number K833405

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HQC 1984-01-04

BEECHER 20 GA. PROBE

Applicant Beecher Medical Diagnostic Instrumentation

K number K833800

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HQC 1984-01-04

STORZ EXTRA

Applicant Storz Instrument Co.

K number K833064

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HQC 1984-01-04

M.S.D. ASPIRATOR

Applicant Medical Surgical Designs

K number K832529

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HQC 1983-12-28

UNIVERSAL PAC

Applicant American Surgical Co., Inc.

K number K834161

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HQC 1983-12-28

PHACOTRON PLUS

Applicant American Surgical Co., Inc.

K number K834159

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HQC 1983-12-28

EXTRA SENSORY PLUS

Applicant American Surgical Co., Inc.

K number K834158

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HQC 1983-12-28

EXTRA SENSORY PAK-DISPOS. ACCESS

Applicant American Surgical Co., Inc.

K number K833697

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HQC 1983-12-28

EXTRA PLUS TM

Applicant American Surgical Co., Inc.

K number K833617

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HQC 1983-10-19

VXTRA OCUTOME KIT

Applicant Vxtra Corp.

K number K832980

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HQC 1983-10-04

EPA AUTOMATED INFUSION POLE

Applicant Miami Eye Technology, Inc.

K number K832997

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HQC 1983-10-04

SIAS IRRIGATION/ASPIRATION SYSTEM

Applicant Clark Pool & Assoc.

K number K832413

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HQC 1983-09-29

OCUCARE FREEDOM PACK

Applicant Ocular Innovations, Inc.

K number K832559

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HQC 1983-09-12

ENVISION G31 P.E. PAK

Applicant Envision, Inc.

K number K832424

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HQC 1983-09-12

ENVISION G21 I/A ENPAK

Applicant Envision, Inc.

K number K832423

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HQC 1983-07-12

UNIVERSAL PACK

Applicant Atlantic Optical Systems, Inc.

K number K831701

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HQC 1983-06-30

EPSILON ULTRASONIC TIP

Applicant CooperVision, Inc.

K number K831836

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HQC 1983-06-08

ULTRAKIT

Applicant Staar Surgical Co.

K number K831172

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HQC 1983-06-08

ALPHAMEDIX I/A HAND-PIECE, 500-001

Applicant Alphamedix, Inc.

K number K830812

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