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

FDA 510(k) Cleared Keratome, Ac-powered Devices (Product Code HNO)

83 devices
1–24 of 83
Cleared Apr 13, 2018
VisuMax Femtosecond Laser
K173371
Carl Zeiss Meditec, Inc.
Ophthalmic · 168d
Cleared Oct 26, 2017
EPI K Console
K172994
Moria SA
Ophthalmic · 29d
Cleared Jan 16, 2009
EPIVISION SL SYSTEM
K072102
Gebauer Medizintechnik GmbH
Ophthalmic · 535d
Cleared Aug 01, 2008
CARRIAZO-PENDULAR MICROKERATOME
K082043
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 14d
Cleared Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465
Bausch & Lomb, Inc.
Ophthalmic · 13d
Cleared Mar 23, 2006
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K052891
Hawken Industries
Ophthalmic · 161d
Cleared Jul 06, 2005
NORWOOD ABBEY CENTURION SES EPIKERATOME
K051486
Norwood Abbey , Ltd.
Ophthalmic · 30d
Cleared Mar 25, 2005
EPI-K
K043183
Moria SA
Ophthalmic · 128d
Cleared Jan 31, 2005
AMADEUS II EPIKERATOME
K043150
Sis Ltd., Surgical Instrument Systems
Ophthalmic · 77d
Cleared Nov 16, 2004
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K042083
Biovision AG
Ophthalmic · 105d
Cleared Oct 28, 2004
CENTURION SES EPIKERATOME
K042810
Norwood Abbey , Ltd.
Ophthalmic · 16d
Cleared Oct 13, 2004
MB 105 MILLENNIUM BLADES
K041110
Millennium Biomedical, Inc.
Ophthalmic · 168d
Cleared Sep 15, 2004
EPITOME SYSTEM
K041206
Gebauer Medizintechnik GmbH
Ophthalmic · 131d
Cleared Aug 30, 2004
CARRIAZO PENDULAR
K032910
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 343d
Cleared Jun 18, 2004
M3 MICROKERATOME
K032836
Moria SA
Ophthalmic · 281d
Cleared May 25, 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457
Micro Specialties, Inc.
Ophthalmic · 208d
Cleared Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 172d
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 121d
Cleared Jan 13, 2004
MED-LOGICS, MODEL ML7090
K033293
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978
Ciba Vision Corporation
Ophthalmic · 26d
Cleared Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735
Ciba Vision Corporation
Ophthalmic · 78d
Cleared Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401
Oasis Medical, Inc.
Ophthalmic · 133d

About Product Code HNO - Regulatory Context