HNO · Class I · 21 CFR 886.4370

FDA Product Code HNO: Keratome, Ac-powered

Leading manufacturers include Med-Logics, Inc., Oasis Medical, Inc. and Millennium Biomedical, Inc..

83
Total
83
Cleared
118d
Avg days
1976
Since
83 devices
25–48 of 83
Cleared Jun 17, 2003
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
K030891
Surgistar, Inc.
Ophthalmic · 88d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K022982
Med-Logics, Inc.
Ophthalmic · 67d
Cleared Oct 11, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
K022716
Med-Logics, Inc.
Ophthalmic · 57d
Cleared Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
K022205
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Apr 19, 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K020079
Blade Works, Inc.
Ophthalmic · 99d
Cleared Mar 11, 2002
VISTITOME 20-10 MICROKERATOME
K014000
Biovision AG
Ophthalmic · 97d
Cleared Feb 15, 2002
MB 103 MILLENNIUM BLADES
K011833
Millennium Biomedical, Inc.
Ophthalmic · 248d
Cleared Feb 15, 2002
MB 102 MILLENNIUM BLADES
K020122
Millennium Biomedical, Inc.
Ophthalmic · 32d
Cleared Dec 13, 2001
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K013337
Surgin, Inc.
Ophthalmic · 65d
Cleared Nov 06, 2001
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 201d
Cleared Jun 22, 2001
ML BLADE, MODEL ML7030
K010872
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Apr 27, 2001
HANSATOME MICROKERATOME
K010260
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820
Oasis Medical, Inc.
Ophthalmic · 87d
Cleared Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
K002515
Med-Logics, Inc.
Ophthalmic · 191d
Cleared Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
K003143
Millennium Biomedical, Inc.
Ophthalmic · 62d
Cleared Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K002849
Surgical Specialties Corp
Ophthalmic · 35d
Cleared Oct 02, 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464
Oasis
Ophthalmic · 145d
Cleared Sep 21, 2000
DISPOSABLE MICROKERATOME BLADES-PE
K001176
Oasis Medical, Inc.
Ophthalmic · 163d
Cleared Sep 12, 2000
REFRACTIVE SURGERY BLADES
K001806
Millennium Biomedical, Inc.
Ophthalmic · 89d
Cleared May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144
Lasersight Technologies, Inc.
Ophthalmic · 25d
Cleared Mar 20, 2000
BLADEWORKS MICROKERATOME BLADE
K993225
Blade Works, Inc.
Ophthalmic · 175d
Cleared Mar 16, 2000
MSP M/K BLADE
K993122
Medical Sterile Products, Inc.
Ophthalmic · 178d