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 |