HNO · Class I · 21 CFR 886.4370

FDA Product Code HNO: Keratome, Ac-powered

Leading manufacturers include Bausch & Lomb, Inc., Storz Instrument Co. and Ciba Vision Corporation.

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 Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465
Bausch & Lomb, Inc.
Ophthalmic · 13d
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Oct 20, 2003
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K032978
Ciba Vision Corporation
Ophthalmic · 26d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735
Ciba Vision Corporation
Ophthalmic · 78d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Apr 27, 2001
HANSATOME MICROKERATOME
K010260
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Sep 24, 1999
MICROKERATOME, MODEL MK-2000
K990900
Nidek, Inc.
Ophthalmic · 190d
Cleared May 22, 1991
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062
Storz Instrument Co.
Ophthalmic · 72d
Cleared Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
K904845
Storz Instrument Co.
Ophthalmic · 89d
Cleared Oct 05, 1976
ELECTRO-KERATOTOME, LINE-OPERATED
K760726
Storz Instrument Co.
Ophthalmic · 8d

About Product Code HNO - Regulatory Context