HNO · Keratome, Ac-Powered
Ophthalmic · 21 CFR 886.4370 · Class 1
Overview
| Product Code | HNO |
|---|---|
| Device Name | Keratome, Ac-Powered |
| Regulation | 21 CFR 886.4370 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
Classification Rationale
Class I.
Cleared Devices (83)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | Apr 13, 2018 | SESE |
| K172994 | EPI K Console | Moria SA | Oct 26, 2017 | SESE |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | Jan 16, 2009 | SESE |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 1, 2008 | SESE |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | Sep 6, 2006 | SESE |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | Mar 23, 2006 | SESE |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Jul 6, 2005 | SESE |
| K043183 | EPI-K | Moria SA | Mar 25, 2005 | SESE |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | Jan 31, 2005 | SESE |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | Nov 16, 2004 | SESE |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Oct 28, 2004 | SESE |
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Oct 13, 2004 | SESE |
| K041206 | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | Sep 15, 2004 | SESE |
| K032910 | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 30, 2004 | SESE |
| K032836 | M3 MICROKERATOME | Moria SA | Jun 18, 2004 | SESE |
| K033457 | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | May 25, 2004 | SESE |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | Mar 26, 2004 | SESE |
| K040204 | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | Mar 22, 2004 | SESE |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | Jan 30, 2004 | SESE |
| K033293 | MED-LOGICS, MODEL ML7090 | Med-Logics, Inc. | Jan 13, 2004 | SESE |
| K032978 | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME | Ciba Vision Corporation | Oct 20, 2003 | SESE |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | Oasis Medical, Inc. | Aug 26, 2003 | SESE |
| K031735 | CENTURION SES EPIKERATOME | Ciba Vision Corporation | Aug 21, 2003 | SESE |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | Oasis Medical, Inc. | Jun 19, 2003 | SESE |
| K030891 | SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK | Surgistar, Inc. | Jun 17, 2003 | SESE |
| K020482 | KERATOME BLADE 200200 & 600600 | Micro Specialties, Inc. | Dec 16, 2002 | SESE |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | Med-Logics, Inc. | Nov 15, 2002 | SESE |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | Med-Logics, Inc. | Oct 11, 2002 | SESE |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | Oasis Medical, Inc. | Oct 3, 2002 | SESE |
| K021640 | HANSATOME EXCELLUS MICROKERATOME | Bausch & Lomb, Inc. | Jun 19, 2002 | SESE |
| K020079 | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 | Blade Works, Inc. | Apr 19, 2002 | SESE |
| K014000 | VISTITOME 20-10 MICROKERATOME | Biovision AG | Mar 11, 2002 | SESE |
| K020122 | MB 102 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Feb 15, 2002 | SESE |
| K011833 | MB 103 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Feb 15, 2002 | SESE |
| K013337 | PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI | Surgin, Inc. | Dec 13, 2001 | SESE |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | Surgin Surgical Instrumentation, Inc. | Nov 6, 2001 | SESE |
| K010872 | ML BLADE, MODEL ML7030 | Med-Logics, Inc. | Jun 22, 2001 | SESE |
| K010260 | HANSATOME MICROKERATOME | Bausch & Lomb, Inc. | Apr 27, 2001 | SESE |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Oasis Medical, Inc. | Mar 8, 2001 | SESE |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | Med-Logics, Inc. | Feb 22, 2001 | SESE |
| K003143 | MILLENNIUM BLADES, MODEL MB101 | Millennium Biomedical, Inc. | Dec 11, 2000 | SESE |
| K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES | Surgical Specialties Corp | Oct 18, 2000 | SESE |
| K001464 | DISPOSABLE H-PE MICROKERATOME BLADES | Oasis | Oct 2, 2000 | SESE |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Oasis Medical, Inc. | Sep 21, 2000 | SESE |
| K001806 | REFRACTIVE SURGERY BLADES | Millennium Biomedical, Inc. | Sep 12, 2000 | SESE |
| K001144 | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS | Lasersight Technologies, Inc. | May 5, 2000 | SESE |
| K993225 | BLADEWORKS MICROKERATOME BLADE | Blade Works, Inc. | Mar 20, 2000 | SESE |
| K993122 | MSP M/K BLADE | Medical Sterile Products, Inc. | Mar 16, 2000 | SESE |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | Surgin Surgical Instrumentation, Inc. | Mar 15, 2000 | SESE |
| K993190 | ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) | Surgical Instrument Systems (Sis), Ltd. | Feb 10, 2000 | SESE |
| K990227 | ULTRASHAPER KERATOME | Lasersight Technologies, Inc. | Jan 31, 2000 | SESE |
| K992978 | RICROKERATOME BLADE | Surgistar, Inc. | Nov 16, 1999 | SESE |
| K990900 | MICROKERATOME, MODEL MK-2000 | Nidek, Inc. | Sep 24, 1999 | SESE |
| K984540 | KERAVISION VACUUM RING SYSTEM | Keravision, Inc. | Apr 28, 1999 | SESE |
| K981554 | MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) | Micra Instruments , Ltd. | Dec 22, 1998 | SESE |
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME | Summit Technology, Inc. | Dec 22, 1998 | SESE |
| K983317 | BARRON MICROKERATOME SYSTEM, MODEL B2000 | Barron Precision Instruments, LLC | Dec 2, 1998 | SESE |
| K981742 | ONE UP DISPOSABLE KERATOME HEAD | Moria, Inc. | Aug 25, 1998 | SESE |
| K981155 | FLAPMAKER DISPOSABLE MICROKERATOME | Hawken Industries | Aug 14, 1998 | SESE |
| K981071 | ML MICROKERATOME | Med-Logics, Inc. | Jul 23, 1998 | SESE |
| K980985 | SCMD-1000 | Howard Instruments, Inc. | May 1, 1998 | SESE |
| K980510 | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) | Micro Specialties, Inc. | May 1, 1998 | SESE |
| K980508 | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 | Micro Specialties, Inc. | May 1, 1998 | SESE |
| K974598 | MICROKERATOME OR THE MATE | Howard Instruments, Inc. | Apr 22, 1998 | SESE |
| K980924 | PLANCON MICROLAMELLAR KERATOME EVOLUTION | Plancon Instruments | Apr 15, 1998 | SESE |
| K974004 | AUTOMATED DISPOSABLE KERATOME (ADK) | Lasersight Technologies, Inc. | Jan 8, 1998 | SESE |
| K972808 | HANSATOME MICROKERATOME | Chiron Vision Corp. | Oct 24, 1997 | SESE |
| K972727 | CBALK-1000 BLADE | Howard Instruments, Inc. | Oct 10, 1997 | SESE |
| K973294 | INNOVATOME MICROKERATOME | Innovative Optics, Inc. | Oct 3, 1997 | SESE |
| K970377 | PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) | Plancon Instruments | Mar 31, 1997 | SESE |
| K962661 | ML MICROKERATOME BLADE | Med-Logics, Inc. | Dec 9, 1996 | SESE |
| K960395 | PLANCON MIRCOLAMELLAR KERATOME | Plancon Instruments | Apr 26, 1996 | SESE |
| K954058 | BARRAQUER-KRUMEICH REFRACTIVE SET | Eyetech M.V.A. | Nov 6, 1995 | SESE |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Chiron Vision Corp. | Nov 22, 1994 | SESE |
| K935342 | SCMD KERATOME | S.C.M.D. Keratomes of Arizona | Apr 1, 1994 | SESE |
| K913697 | AUTOMATIC CORNEAL SHAPER | Hansa Research & Development, Inc. | Nov 5, 1991 | SESE |
| K911062 | QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY | Storz Instrument Co. | May 22, 1991 | SESE |
| K904845 | STORZ DRAEGER ROTOR KERATOME | Storz Instrument Co. | Jan 22, 1991 | SESE |
| K903912 | KERATOME | Micro Precision Instrument Co. | Oct 17, 1990 | SESE |
| K870807 | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE | Allergan, Inc. | May 29, 1987 | SESE |
| K864065 | BKS-42 DISPOSABLE VACUUM TUBING PACK | Allergan, Inc. | Dec 15, 1986 | SESE |
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | American Medical Optics | Feb 4, 1986 | SESE |
| K760726 | ELECTRO-KERATOTOME, LINE-OPERATED | Storz Instrument Co. | Oct 5, 1976 | SESE |
Top Applicants
- Med-Logics, Inc. — 7 clearances
- Oasis Medical, Inc. — 5 clearances
- Millennium Biomedical, Inc. — 5 clearances
- Surgin Surgical Instrumentation, Inc. — 4 clearances
- Micro Specialties, Inc. — 4 clearances
