FDA 510(k) Applications for Medical Device Product Code "HNO"
(Keratome, Ac-Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K983317 BARRON PRECISION INSTRUMENTS, L.L.C. BARRON MICROKERATOME SYSTEM, MODEL B2000 12/02/1998
K021640 BAUSCH & LOMB, INC. HANSATOME EXCELLUS MICROKERATOME 06/19/2002
K010260 BAUSCH & LOMB, INC. HANSATOME MICROKERATOME 04/27/2001
K062465 BAUSCH & LOMB, INC. ZYOPTIX XP EPI SEPARATOR SYSTEM 09/06/2006
K040204 BAUSCH & LOMB, INC. ZYOPTIX XP MICROKERATOME 03/22/2004
K042083 BIOVISION AG MODIFICATION TO VISITOME 20-10 MICROKERATOME 11/16/2004
K014000 BIOVISION AG VISTITOME 20-10 MICROKERATOME 03/11/2002
K993225 BLADE WORKS, INC. BLADEWORKS MICROKERATOME BLADE 03/20/2000
K020079 BLADE WORKS, INC. BLADEWORKS MICROKERATOME BLADE, MODEL 7061 04/19/2002
K173371 Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser 04/13/2018
K972808 CHIRON VISION CORP. HANSATOME MICROKERATOME 10/24/1997
K031735 CIBA VISION CORPORATION CENTURION SES EPIKERATOME 08/21/2003
K032978 CIBA VISION CORPORATION MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME 10/20/2003
K041206 GEBAUER MEDIZINTECHNIK GMBH EPITOME SYSTEM 09/15/2004
K072102 GEBAUER MEDIZINTECHNIK GMBH EPIVISION SL SYSTEM 01/16/2009
K981155 HAWKEN INDUSTRIES FLAPMAKER DISPOSABLE MICROKERATOME 08/14/1998
K052891 HAWKEN INDUSTRIES HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM 03/23/2006
K972727 HOWARD INSTRUMENTS, INC. CBALK-1000 BLADE 10/10/1997
K974598 HOWARD INSTRUMENTS, INC. MICROKERATOME OR THE MATE 04/22/1998
K980985 HOWARD INSTRUMENTS, INC. SCMD-1000 05/01/1998
K973294 INNOVATIVE OPTICS, INC. INNOVATOME MICROKERATOME 10/03/1997
K984540 KERAVISION, INC. KERAVISION VACUUM RING SYSTEM 04/28/1999
K974004 LASERSIGHT TECHNOLOGIES, INC. AUTOMATED DISPOSABLE KERATOME (ADK) 01/08/1998
K001144 LASERSIGHT TECHNOLOGIES, INC. ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS 05/05/2000
K990227 LASERSIGHT TECHNOLOGIES, INC. ULTRASHAPER KERATOME 01/31/2000
K022716 MED-LOGICS, INC. MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB 10/11/2002
K022982 MED-LOGICS, INC. MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB 11/15/2002
K033293 MED-LOGICS, INC. MED-LOGICS, MODEL ML7090 01/13/2004
K002515 MED-LOGICS, INC. MEDLOGICS ML 4000, MODEL 4000 02/22/2001
K010872 MED-LOGICS, INC. ML BLADE, MODEL ML7030 06/22/2001
K981071 MED-LOGICS, INC. ML MICROKERATOME 07/23/1998
K962661 MED-LOGICS, INC. ML MICROKERATOME BLADE 12/09/1996
K993122 MEDICAL STERILE PRODUCTS, INC. MSP M/K BLADE 03/16/2000
K981554 MICRA INSTRUMENTS LTD. MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) 12/22/1998
K033457 MICRO SPECIALTIES, INC. M2 COMPATIBLE MICROKERATOME BLADE 05/25/2004
K980510 MICROSPECIALTIES, INC. KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) 05/01/1998
K020482 MICROSPECIALTIES, INC. KERATOME BLADE 200200 & 600600 12/16/2002
K980508 MICROSPECIALTIES, INC. KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 05/01/1998
K020122 MILLENNIUM BIOMEDICAL, INC. MB 102 MILLENNIUM BLADES 02/15/2002
K011833 MILLENNIUM BIOMEDICAL, INC. MB 103 MILLENNIUM BLADES 02/15/2002
K041110 MILLENNIUM BIOMEDICAL, INC. MB 105 MILLENNIUM BLADES 10/13/2004
K003143 MILLENNIUM BIOMEDICAL, INC. MILLENNIUM BLADES, MODEL MB101 12/11/2000
K001806 MILLENNIUM BIOMEDICAL, INC. REFRACTIVE SURGERY BLADES 09/12/2000
K043183 MORIA S.A. EPI-K 03/25/2005
K032836 MORIA S.A. M3 MICROKERATOME 06/18/2004
K172994 Moria SA EPI K Console 10/26/2017
K981742 MORIA, INC. ONE UP DISPOSABLE KERATOME HEAD 08/25/1998
K990900 NIDEK, INC. MICROKERATOME, MODEL MK-2000 09/24/1999
K042810 NORWOOD ABBEY , LTD. CENTURION SES EPIKERATOME 10/28/2004
K051486 NORWOOD ABBEY , LTD. NORWOOD ABBEY CENTURION SES EPIKERATOME 07/06/2005
K001464 OASIS DISPOSABLE H-PE MICROKERATOME BLADES 10/02/2000
K003820 OASIS MEDICAL, INC. DISPOSABLE CB-PE MICROKERATOME BLADES 03/08/2001
K030401 OASIS MEDICAL, INC. DISPOSABLE M2-PE MICROKERATOME BLADES 06/19/2003
K001176 OASIS MEDICAL, INC. DISPOSABLE MICROKERATOME BLADES-PE 09/21/2000
K032297 OASIS MEDICAL, INC. DISPOSABLE N-PE MICKROKERATOME BLADES 08/26/2003
K022205 OASIS MEDICAL, INC. DISPOSABLE N-PE MICROKERATOME BLADES 10/03/2002
K970377 PLANCON INSTRUMENTS PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) 03/31/1997
K980924 PLANCON INSTRUMENTS PLANCON MICROLAMELLAR KERATOME EVOLUTION 04/15/1998
K960395 PLANCON INSTRUMENTS PLANCON MIRCOLAMELLAR KERATOME 04/26/1996
K032910 SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG CARRIAZO PENDULAR 08/30/2004
K082043 SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG CARRIAZO-PENDULAR MICROKERATOME 08/01/2008
K043150 SIS LTD. SURGICAL INSTRUMENT SYSTEMS AMADEUS II EPIKERATOME 01/31/2005
K980675 SUMMIT TECHNOLOGY, INC. SUMMIT KRUMEICH-BARRAQUER MICROKERATOME 12/22/1998
K993190 SURGICAL INSTRUMENT SYSTEMS (SIS), LTD ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) 02/10/2000
K002849 SURGICAL SPECIALTIES CORP. PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES 10/18/2000
K013337 SURGIN INC PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI 12/13/2001
K994015 SURGIN SURGICAL INSTRUMENTATION, INC. ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 03/15/2000
K011195 SURGIN SURGICAL INSTRUMENTATION, INC. PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB 11/06/2001
K033182 SURGIN SURGICAL INSTRUMENTATION, INC. PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD 01/30/2004
K033236 SURGIN SURGICAL INSTRUMENTATION, INC. PRIZM KERATOME BLADE, MODEL MK8512M2 03/26/2004
K992978 SURGISTAR, INC. RICROKERATOME BLADE 11/16/1999
K030891 SURGISTAR, INC. SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK 06/17/2003


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