FDA Product Code
FDA Product Code HNO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4370
510(k) Clearances — 83 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | 2018-04-13 | Traditional | PDF ↗ |
| K172994 | EPI K Console | Moria SA | 2017-10-26 | Special | PDF ↗ |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | 2009-01-16 | Traditional | PDF ↗ |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 | Traditional | PDF ↗ |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | 2006-09-06 | Traditional | PDF ↗ |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | 2006-03-23 | Traditional | PDF ↗ |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2005-07-06 | Special | PDF ↗ |
| K043183 | EPI-K | Moria SA | 2005-03-25 | Traditional | PDF ↗ |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | 2005-01-31 | Special | PDF ↗ |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | 2004-11-16 | Traditional | PDF ↗ |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2004-10-28 | Special | PDF ↗ |
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2004-10-13 | Traditional | PDF ↗ |
| K041206 | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | 2004-09-15 | Traditional | PDF ↗ |
| K032910 | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004-08-30 | Traditional | PDF ↗ |
| K032836 | M3 MICROKERATOME | Moria SA | 2004-06-18 | Traditional | PDF ↗ |
| K033457 | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | 2004-05-25 | Traditional | PDF ↗ |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K040204 | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | 2004-03-22 | Special | PDF ↗ |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | 2004-01-30 | Traditional | PDF ↗ |
| K033293 | MED-LOGICS, MODEL ML7090 | Med-Logics, Inc. | 2004-01-13 | Traditional | PDF ↗ |
| K032978 | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME | Ciba Vision Corporation | 2003-10-20 | Special | PDF ↗ |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | Oasis Medical, Inc. | 2003-08-26 | Special | PDF ↗ |
| K031735 | CENTURION SES EPIKERATOME | Ciba Vision Corporation | 2003-08-21 | Traditional | PDF ↗ |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | Oasis Medical, Inc. | 2003-06-19 | Traditional | PDF ↗ |
| K030891 | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK | Surgistar, Inc. | 2003-06-17 | Traditional | PDF ↗ |
| K020482 | KERATOME BLADE 200200 & 600600 | Micro Specialties, Inc. | 2002-12-16 | Traditional | PDF ↗ |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | Med-Logics, Inc. | 2002-11-15 | Traditional | PDF ↗ |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | Med-Logics, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | Oasis Medical, Inc. | 2002-10-03 | Traditional | PDF ↗ |
| K021640 | HANSATOME EXCELLUS MICROKERATOME | Bausch & Lomb, Inc. | 2002-06-19 | Special | PDF ↗ |
| K020079 | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 | Blade Works, Inc. | 2002-04-19 | Traditional | PDF ↗ |
| K014000 | VISTITOME 20-10 MICROKERATOME | Biovision AG | 2002-03-11 | Traditional | PDF ↗ |
| K011833 | MB 103 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2002-02-15 | Traditional | PDF ↗ |
| K020122 | MB 102 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2002-02-15 | Traditional | PDF ↗ |
| K013337 | PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI | Surgin, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | Surgin Surgical Instrumentation, Inc. | 2001-11-06 | Traditional | PDF ↗ |
| K010872 | ML BLADE, MODEL ML7030 | Med-Logics, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K010260 | HANSATOME MICROKERATOME | Bausch & Lomb, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Oasis Medical, Inc. | 2001-03-08 | Traditional | PDF ↗ |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | Med-Logics, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K003143 | MILLENNIUM BLADES, MODEL MB101 | Millennium Biomedical, Inc. | 2000-12-11 | Traditional | PDF ↗ |
| K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES | Surgical Specialties Corp | 2000-10-18 | Traditional | PDF ↗ |
| K001464 | DISPOSABLE H-PE MICROKERATOME BLADES | Oasis | 2000-10-02 | Traditional | PDF ↗ |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Oasis Medical, Inc. | 2000-09-21 | Traditional | PDF ↗ |
| K001806 | REFRACTIVE SURGERY BLADES | Millennium Biomedical, Inc. | 2000-09-12 | Traditional | PDF ↗ |
| K001144 | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS | Lasersight Technologies, Inc. | 2000-05-05 | Traditional | PDF ↗ |
| K993225 | BLADEWORKS MICROKERATOME BLADE | Blade Works, Inc. | 2000-03-20 | Traditional | PDF ↗ |
| K993122 | MSP M/K BLADE | Medical Sterile Products, Inc. | 2000-03-16 | Traditional | PDF ↗ |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | Surgin Surgical Instrumentation, Inc. | 2000-03-15 | Traditional | PDF ↗ |
| K993190 | ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) | Surgical Instrument Systems (Sis), Ltd. | 2000-02-10 | Traditional | PDF ↗ |
| K990227 | ULTRASHAPER KERATOME | Lasersight Technologies, Inc. | 2000-01-31 | Traditional | PDF ↗ |
| K992978 | RICROKERATOME BLADE | Surgistar, Inc. | 1999-11-16 | Traditional | PDF ↗ |
| K990900 | MICROKERATOME, MODEL MK-2000 | Nidek, Inc. | 1999-09-24 | Traditional | PDF ↗ |
| K984540 | KERAVISION VACUUM RING SYSTEM | Keravision, Inc. | 1999-04-28 | Abbreviated | PDF ↗ |
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME | Summit Technology, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K981554 | MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) | Micra Instruments , Ltd. | 1998-12-22 | Traditional | PDF ↗ |
| K983317 | BARRON MICROKERATOME SYSTEM, MODEL B2000 | Barron Precision Instruments, LLC | 1998-12-02 | Traditional | PDF ↗ |
| K981742 | ONE UP DISPOSABLE KERATOME HEAD | Moria, Inc. | 1998-08-25 | Traditional | PDF ↗ |
| K981155 | FLAPMAKER DISPOSABLE MICROKERATOME | Hawken Industries | 1998-08-14 | Traditional | PDF ↗ |
| K981071 | ML MICROKERATOME | Med-Logics, Inc. | 1998-07-23 | Traditional | PDF ↗ |
| K980985 | SCMD-1000 | Howard Instruments, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K980508 | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 | Micro Specialties, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K980510 | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) | Micro Specialties, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K974598 | MICROKERATOME OR THE MATE | Howard Instruments, Inc. | 1998-04-22 | Traditional | PDF ↗ |
| K980924 | PLANCON MICROLAMELLAR KERATOME EVOLUTION | Plancon Instruments | 1998-04-15 | Traditional | PDF ↗ |
| K974004 | AUTOMATED DISPOSABLE KERATOME (ADK) | Lasersight Technologies, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K972808 | HANSATOME MICROKERATOME | Chiron Vision Corp. | 1997-10-24 | Traditional | PDF ↗ |
| K972727 | CBALK-1000 BLADE | Howard Instruments, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K973294 | INNOVATOME MICROKERATOME | Innovative Optics, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K970377 | PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) | Plancon Instruments | 1997-03-31 | Traditional | PDF ↗ |
| K962661 | ML MICROKERATOME BLADE | Med-Logics, Inc. | 1996-12-09 | Traditional | PDF ↗ |
| K960395 | PLANCON MIRCOLAMELLAR KERATOME | Plancon Instruments | 1996-04-26 | Traditional | PDF ↗ |
| K954058 | BARRAQUER-KRUMEICH REFRACTIVE SET | Eyetech M.V.A. | 1995-11-06 | Traditional | PDF ↗ |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Chiron Vision Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K935342 | SCMD KERATOME | S.C.M.D. Keratomes of Arizona | 1994-04-01 | Traditional | PDF ↗ |
| K913697 | AUTOMATIC CORNEAL SHAPER | Hansa Research & Development, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K911062 | QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY | Storz Instrument Co. | 1991-05-22 | Traditional | PDF ↗ |
| K904845 | STORZ DRAEGER ROTOR KERATOME | Storz Instrument Co. | 1991-01-22 | Traditional | PDF ↗ |
| K903912 | KERATOME | Micro Precision Instrument Co. | 1990-10-17 | Traditional | PDF ↗ |
| K870807 | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE | Allergan, Inc. | 1987-05-29 | Traditional | PDF ↗ |
| K864065 | BKS-42 DISPOSABLE VACUUM TUBING PACK | Allergan, Inc. | 1986-12-15 | Traditional | PDF ↗ |
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | American Medical Optics | 1986-02-04 | Traditional | PDF ↗ |
| K760726 | ELECTRO-KERATOTOME, LINE-OPERATED | Storz Instrument Co. | 1976-10-05 | Traditional | PDF ↗ |
Product code HNO · Class I · Ophthalmic. Data: openFDA.