HNO · Class I · 21 CFR 886.4370

FDA Product Code HNO: Keratome, Ac-powered

Leading manufacturers include Oasis Medical, Inc., Bausch & Lomb, Inc. and Surgin Surgical Instrumentation, Inc..

83
Total
83
Cleared
118d
Avg days
1976
Since
83 devices
25–48 of 83
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
Cleared Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 110d
Cleared Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K993190
Surgical Instrument Systems (Sis), Ltd.
Ophthalmic · 140d
Cleared Jan 31, 2000
ULTRASHAPER KERATOME
K990227
Lasersight Technologies, Inc.
Ophthalmic · 371d
Cleared Nov 16, 1999
RICROKERATOME BLADE
K992978
Surgistar, Inc.
Ophthalmic · 74d
Cleared Sep 24, 1999
MICROKERATOME, MODEL MK-2000
K990900
Nidek, Inc.
Ophthalmic · 190d
Cleared Apr 28, 1999
KERAVISION VACUUM RING SYSTEM
K984540
Keravision, Inc.
Ophthalmic · 128d
Cleared Dec 22, 1998
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675
Summit Technology, Inc.
Ophthalmic · 305d
Cleared Dec 22, 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554
Micra Instruments , Ltd.
Ophthalmic · 235d
Cleared Dec 02, 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317
Barron Precision Instruments, LLC
Ophthalmic · 72d
Cleared Aug 25, 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742
Moria, Inc.
Ophthalmic · 99d
Cleared Aug 14, 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155
Hawken Industries
Ophthalmic · 136d
Cleared Jul 23, 1998
ML MICROKERATOME
K981071
Med-Logics, Inc.
Ophthalmic · 121d
Cleared May 01, 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
K980510
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
SCMD-1000
K980985
Howard Instruments, Inc.
Ophthalmic · 45d
Cleared Apr 22, 1998
MICROKERATOME OR THE MATE
K974598
Howard Instruments, Inc.
Ophthalmic · 134d
Cleared Apr 15, 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924
Plancon Instruments
Ophthalmic · 35d
Cleared Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004
Lasersight Technologies, Inc.
Ophthalmic · 79d
Cleared Oct 24, 1997
HANSATOME MICROKERATOME
K972808
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Oct 10, 1997
CBALK-1000 BLADE
K972727
Howard Instruments, Inc.
Ophthalmic · 81d
Cleared Oct 03, 1997
INNOVATOME MICROKERATOME
K973294
Innovative Optics, Inc.
Ophthalmic · 31d
Cleared Mar 31, 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377
Plancon Instruments
Ophthalmic · 56d