HMY · Class I · 21 CFR 886.4370

FDA Product Code HMY: Keratome, Battery-powered

Leading manufacturers include Moria, Inc., Moria SA and Becton, Dickinson & CO.

12
Total
12
Cleared
68d
Avg days
1978
Since

FDA 510(k) Cleared Keratome, Battery-powered Devices (Product Code HMY)

12 devices
1–12 of 12
Cleared Mar 31, 2004
ONEUSE- PLUS MICROKERATOME
K040297
Moria SA
Ophthalmic · 51d
Cleared Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
K023092
Becton, Dickinson & CO
Ophthalmic · 30d
Cleared Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637
Becton, Dickinson & CO
Ophthalmic · 69d
Cleared Sep 27, 2002
M2 SINGLE USE MICROKERTOME
K022560
Moria SA
Ophthalmic · 56d
Cleared Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594
Moria, Inc.
Ophthalmic · 108d
Cleared Oct 12, 2000
CARRIAZO BARRAQUER II MICROKERATOME
K002191
Moria, Inc.
Ophthalmic · 84d
Cleared Sep 24, 1999
MILLENIUM MICROKERATOME, MODEL IMD-001
K992687
Industrial & Medical Design, Inc.
Ophthalmic · 45d
Cleared May 14, 1999
KERATOME SYSTEM, MODEL K3000
K984537
Insight Technologies Instruments, LLC
Ophthalmic · 144d
Cleared Jul 24, 1998
CARRIAZO BARRAQUER MICROKERATOME
K981741
Moria, Inc.
Ophthalmic · 67d
Cleared Jan 20, 1998
KERATOME SYSTEM
K974243
Insight Technologies Instruments, LLC
Ophthalmic · 69d
Cleared Jul 31, 1990
VISI-DRAPE OPHTHALMIC DRAPES
K902857
Visitec Co.
Ophthalmic · 32d
Cleared Oct 11, 1978
OSCILLATING KNIFE AND ACCESSORIES
K781412
Codman & Shurtleff, Inc.
Ophthalmic · 57d

About Product Code HMY - Regulatory Context