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Keratome, Ac-Powered

FDA product code HNO · 83 cleared devices

Class 1 Ophthalmic

Regulation: 21 CFR 886.4370
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-05 – 2018-04-13

HNO 2018-04-13

VisuMax Femtosecond Laser

Applicant Carl Zeiss Meditec, Inc.

K number K173371

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HNO 2017-10-26

EPI K Console

Applicant Moria SA

K number K172994

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HNO 2009-01-16

EPIVISION SL SYSTEM

Applicant Gebauer Medizintechnik GmbH

K number K072102

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HNO 2008-08-01

CARRIAZO-PENDULAR MICROKERATOME

Applicant Schwind Eye-Tech-Solutions GmbH & Co. KG

K number K082043

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HNO 2006-09-06

ZYOPTIX XP EPI SEPARATOR SYSTEM

Applicant Bausch & Lomb, Inc.

K number K062465

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HNO 2006-03-23

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

Applicant Hawken Industries

K number K052891

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HNO 2005-07-06

NORWOOD ABBEY CENTURION SES EPIKERATOME

Applicant Norwood Abbey , Ltd.

K number K051486

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HNO 2005-03-25

EPI-K

Applicant Moria SA

K number K043183

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HNO 2005-01-31

AMADEUS II EPIKERATOME

Applicant Sis Ltd., Surgical Instrument Systems

K number K043150

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HNO 2004-11-16

MODIFICATION TO VISITOME 20-10 MICROKERATOME

Applicant Biovision AG

K number K042083

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HNO 2004-10-28

CENTURION SES EPIKERATOME

Applicant Norwood Abbey , Ltd.

K number K042810

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HNO 2004-10-13

MB 105 MILLENNIUM BLADES

Applicant Millennium Biomedical, Inc.

K number K041110

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HNO 2004-09-15

EPITOME SYSTEM

Applicant Gebauer Medizintechnik GmbH

K number K041206

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HNO 2004-08-30

CARRIAZO PENDULAR

Applicant Schwind Eye-Tech-Solutions GmbH & Co. KG

K number K032910

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HNO 2004-06-18

M3 MICROKERATOME

Applicant Moria SA

K number K032836

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HNO 2004-05-25

M2 COMPATIBLE MICROKERATOME BLADE

Applicant Micro Specialties, Inc.

K number K033457

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HNO 2004-03-26

PRIZM KERATOME BLADE, MODEL MK8512M2

Applicant Surgin Surgical Instrumentation, Inc.

K number K033236

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HNO 2004-03-22

ZYOPTIX XP MICROKERATOME

Applicant Bausch & Lomb, Inc.

K number K040204

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HNO 2004-01-30

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD

Applicant Surgin Surgical Instrumentation, Inc.

K number K033182

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HNO 2004-01-13

MED-LOGICS, MODEL ML7090

Applicant Med-Logics, Inc.

K number K033293

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HNO 2003-10-20

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

Applicant Ciba Vision Corporation

K number K032978

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HNO 2003-08-26

DISPOSABLE N-PE MICKROKERATOME BLADES

Applicant Oasis Medical, Inc.

K number K032297

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HNO 2003-08-21

CENTURION SES EPIKERATOME

Applicant Ciba Vision Corporation

K number K031735

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HNO 2003-06-19

DISPOSABLE M2-PE MICROKERATOME BLADES

Applicant Oasis Medical, Inc.

K number K030401

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HNO 2003-06-17

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK

Applicant Surgistar, Inc.

K number K030891

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HNO 2002-12-16

KERATOME BLADE 200200 & 600600

Applicant Micro Specialties, Inc.

K number K020482

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HNO 2002-11-15

MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB

Applicant Med-Logics, Inc.

K number K022982

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HNO 2002-10-11

MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB

Applicant Med-Logics, Inc.

K number K022716

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HNO 2002-10-03

DISPOSABLE N-PE MICROKERATOME BLADES

Applicant Oasis Medical, Inc.

K number K022205

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HNO 2002-06-19

HANSATOME EXCELLUS MICROKERATOME

Applicant Bausch & Lomb, Inc.

K number K021640

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HNO 2002-04-19

BLADEWORKS MICROKERATOME BLADE, MODEL 7061

Applicant Blade Works, Inc.

K number K020079

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HNO 2002-03-11

VISTITOME 20-10 MICROKERATOME

Applicant Biovision AG

K number K014000

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HNO 2002-02-15

MB 102 MILLENNIUM BLADES

Applicant Millennium Biomedical, Inc.

K number K020122

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HNO 2002-02-15

MB 103 MILLENNIUM BLADES

Applicant Millennium Biomedical, Inc.

K number K011833

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HNO 2001-12-13

PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI

Applicant Surgin, Inc.

K number K013337

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HNO 2001-11-06

PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB

Applicant Surgin Surgical Instrumentation, Inc.

K number K011195

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HNO 2001-06-22

ML BLADE, MODEL ML7030

Applicant Med-Logics, Inc.

K number K010872

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HNO 2001-04-27

HANSATOME MICROKERATOME

Applicant Bausch & Lomb, Inc.

K number K010260

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HNO 2001-03-08

DISPOSABLE CB-PE MICROKERATOME BLADES

Applicant Oasis Medical, Inc.

K number K003820

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HNO 2001-02-22

MEDLOGICS ML 4000, MODEL 4000

Applicant Med-Logics, Inc.

K number K002515

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HNO 2000-12-11

MILLENNIUM BLADES, MODEL MB101

Applicant Millennium Biomedical, Inc.

K number K003143

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HNO 2000-10-18

PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

Applicant Surgical Specialties Corp

K number K002849

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HNO 2000-10-02

DISPOSABLE H-PE MICROKERATOME BLADES

Applicant Oasis

K number K001464

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HNO 2000-09-21

DISPOSABLE MICROKERATOME BLADES-PE

Applicant Oasis Medical, Inc.

K number K001176

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HNO 2000-09-12

REFRACTIVE SURGERY BLADES

Applicant Millennium Biomedical, Inc.

K number K001806

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HNO 2000-05-05

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS

Applicant Lasersight Technologies, Inc.

K number K001144

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HNO 2000-03-20

BLADEWORKS MICROKERATOME BLADE

Applicant Blade Works, Inc.

K number K993225

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HNO 2000-03-16

MSP M/K BLADE

Applicant Medical Sterile Products, Inc.

K number K993122

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HNO 2000-03-15

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

Applicant Surgin Surgical Instrumentation, Inc.

K number K994015

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HNO 2000-02-10

ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)

Applicant Surgical Instrument Systems (Sis), Ltd.

K number K993190

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HNO 2000-01-31

ULTRASHAPER KERATOME

Applicant Lasersight Technologies, Inc.

K number K990227

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HNO 1999-11-16

RICROKERATOME BLADE

Applicant Surgistar, Inc.

K number K992978

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HNO 1999-09-24

MICROKERATOME, MODEL MK-2000

Applicant Nidek, Inc.

K number K990900

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HNO 1999-04-28

KERAVISION VACUUM RING SYSTEM

Applicant Keravision, Inc.

K number K984540

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HNO 1998-12-22

MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)

Applicant Micra Instruments , Ltd.

K number K981554

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HNO 1998-12-22

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME

Applicant Summit Technology, Inc.

K number K980675

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HNO 1998-12-02

BARRON MICROKERATOME SYSTEM, MODEL B2000

Applicant Barron Precision Instruments, LLC

K number K983317

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HNO 1998-08-25

ONE UP DISPOSABLE KERATOME HEAD

Applicant Moria, Inc.

K number K981742

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HNO 1998-08-14

FLAPMAKER DISPOSABLE MICROKERATOME

Applicant Hawken Industries

K number K981155

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HNO 1998-07-23

ML MICROKERATOME

Applicant Med-Logics, Inc.

K number K981071

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HNO 1998-05-01

SCMD-1000

Applicant Howard Instruments, Inc.

K number K980985

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HNO 1998-05-01

KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)

Applicant Micro Specialties, Inc.

K number K980510

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HNO 1998-05-01

KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400

Applicant Micro Specialties, Inc.

K number K980508

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HNO 1998-04-22

MICROKERATOME OR THE MATE

Applicant Howard Instruments, Inc.

K number K974598

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HNO 1998-04-15

PLANCON MICROLAMELLAR KERATOME EVOLUTION

Applicant Plancon Instruments

K number K980924

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HNO 1998-01-08

AUTOMATED DISPOSABLE KERATOME (ADK)

Applicant Lasersight Technologies, Inc.

K number K974004

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HNO 1997-10-24

HANSATOME MICROKERATOME

Applicant Chiron Vision Corp.

K number K972808

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HNO 1997-10-10

CBALK-1000 BLADE

Applicant Howard Instruments, Inc.

K number K972727

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HNO 1997-10-03

INNOVATOME MICROKERATOME

Applicant Innovative Optics, Inc.

K number K973294

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HNO 1997-03-31

PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)

Applicant Plancon Instruments

K number K970377

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HNO 1996-12-09

ML MICROKERATOME BLADE

Applicant Med-Logics, Inc.

K number K962661

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HNO 1996-04-26

PLANCON MIRCOLAMELLAR KERATOME

Applicant Plancon Instruments

K number K960395

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HNO 1995-11-06

BARRAQUER-KRUMEICH REFRACTIVE SET

Applicant Eyetech M.V.A.

K number K954058

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HNO 1994-11-22

AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT

Applicant Chiron Vision Corp.

K number K941550

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HNO 1994-04-01

SCMD KERATOME

Applicant S.C.M.D. Keratomes of Arizona

K number K935342

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HNO 1991-11-05

AUTOMATIC CORNEAL SHAPER

Applicant Hansa Research & Development, Inc.

K number K913697

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HNO 1991-05-22

QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY

Applicant Storz Instrument Co.

K number K911062

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HNO 1991-01-22

STORZ DRAEGER ROTOR KERATOME

Applicant Storz Instrument Co.

K number K904845

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HNO 1990-10-17

KERATOME

Applicant Micro Precision Instrument Co.

K number K903912

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HNO 1987-05-29

BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE

Applicant Allergan, Inc.

K number K870807

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HNO 1986-12-15

BKS-42 DISPOSABLE VACUUM TUBING PACK

Applicant Allergan, Inc.

K number K864065

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HNO 1986-02-04

BARRAQUER-KRUMEICH REFRACTIVE SET

Applicant American Medical Optics

K number K860001

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HNO 1976-10-05

ELECTRO-KERATOTOME, LINE-OPERATED

Applicant Storz Instrument Co.

K number K760726

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