Product Code: HNO FDA class 1 21 CFR 886.4370

Keratome, Ac-Powered

Ophthalmic

An AC-Powered Keratome is an electrically powered surgical instrument used to make precise lamellar cuts in the cornea, particularly in keratoplasty (corneal transplantation) or refractive surgical procedures. This device is FDA Class 1 (lowest risk), subject to general controls only and not requiring premarket approval. It carries product code HNO and is regulated under 21 CFR 886.4370, within the Ophthalmic medical specialty. It is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: HNO
Device Class: FDA class 1
Regulation Number: 886.4370
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 83 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K173371	VisuMax Femtosecond Laser	Apr 13, 2018	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K172994	EPI K Console	Oct 26, 2017	Substantially Equivalent	Moria SA
K072102	EPIVISION SL SYSTEM	Jan 16, 2009	Substantially Equivalent	Gebauer Medizintechnik GmbH
K082043	CARRIAZO-PENDULAR MICROKERATOME	Aug 01, 2008	Substantially Equivalent	Schwind Eye-Tech-Solutions GmbH & Co. KG
K062465	ZYOPTIX XP EPI SEPARATOR SYSTEM	Sep 06, 2006	Substantially Equivalent	Bausch & Lomb, Inc.
K052891	HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM	Mar 23, 2006	Substantially Equivalent	Hawken Industries
K051486	NORWOOD ABBEY CENTURION SES EPIKERATOME	Jul 06, 2005	Substantially Equivalent	Norwood Abbey , Ltd.
K043183	EPI-K	Mar 25, 2005	Substantially Equivalent	Moria SA
K043150	AMADEUS II EPIKERATOME	Jan 31, 2005	Substantially Equivalent	Sis Ltd., Surgical Instrument Systems
K042083	MODIFICATION TO VISITOME 20-10 MICROKERATOME	Nov 16, 2004	Substantially Equivalent	Biovision AG
K042810	CENTURION SES EPIKERATOME	Oct 28, 2004	Substantially Equivalent	Norwood Abbey , Ltd.
K041110	MB 105 MILLENNIUM BLADES	Oct 13, 2004	Substantially Equivalent	Millennium Biomedical, Inc.
K041206	EPITOME SYSTEM	Sep 15, 2004	Substantially Equivalent	Gebauer Medizintechnik GmbH
K032910	CARRIAZO PENDULAR	Aug 30, 2004	Substantially Equivalent	Schwind Eye-Tech-Solutions GmbH & Co. KG
K032836	M3 MICROKERATOME	Jun 18, 2004	Substantially Equivalent	Moria SA
K033457	M2 COMPATIBLE MICROKERATOME BLADE	May 25, 2004	Substantially Equivalent	Micro Specialties, Inc.
K033236	PRIZM KERATOME BLADE, MODEL MK8512M2	Mar 26, 2004	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K040204	ZYOPTIX XP MICROKERATOME	Mar 22, 2004	Substantially Equivalent	Bausch & Lomb, Inc.
K033182	PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD	Jan 30, 2004	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K033293	MED-LOGICS, MODEL ML7090	Jan 13, 2004	Substantially Equivalent	Med-Logics, Inc.
K032978	MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME	Oct 20, 2003	Substantially Equivalent	Ciba Vision Corporation
K032297	DISPOSABLE N-PE MICKROKERATOME BLADES	Aug 26, 2003	Substantially Equivalent	Oasis Medical, Inc.
K031735	CENTURION SES EPIKERATOME	Aug 21, 2003	Substantially Equivalent	Ciba Vision Corporation
K030401	DISPOSABLE M2-PE MICROKERATOME BLADES	Jun 19, 2003	Substantially Equivalent	Oasis Medical, Inc.
K030891	SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK	Jun 17, 2003	Substantially Equivalent	Surgistar, Inc.
K020482	KERATOME BLADE 200200 & 600600	Dec 16, 2002	Substantially Equivalent	Micro Specialties, Inc.
K022982	MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB	Nov 15, 2002	Substantially Equivalent	Med-Logics, Inc.
K022716	MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB	Oct 11, 2002	Substantially Equivalent	Med-Logics, Inc.
K022205	DISPOSABLE N-PE MICROKERATOME BLADES	Oct 03, 2002	Substantially Equivalent	Oasis Medical, Inc.
K021640	HANSATOME EXCELLUS MICROKERATOME	Jun 19, 2002	Substantially Equivalent	Bausch & Lomb, Inc.
K020079	BLADEWORKS MICROKERATOME BLADE, MODEL 7061	Apr 19, 2002	Substantially Equivalent	Blade Works, Inc.
K014000	VISTITOME 20-10 MICROKERATOME	Mar 11, 2002	Substantially Equivalent	Biovision AG
K020122	MB 102 MILLENNIUM BLADES	Feb 15, 2002	Substantially Equivalent	Millennium Biomedical, Inc.
K011833	MB 103 MILLENNIUM BLADES	Feb 15, 2002	Substantially Equivalent	Millennium Biomedical, Inc.
K013337	PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI	Dec 13, 2001	Substantially Equivalent	Surgin, Inc.
K011195	PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB	Nov 06, 2001	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K010872	ML BLADE, MODEL ML7030	Jun 22, 2001	Substantially Equivalent	Med-Logics, Inc.
K010260	HANSATOME MICROKERATOME	Apr 27, 2001	Substantially Equivalent	Bausch & Lomb, Inc.
K003820	DISPOSABLE CB-PE MICROKERATOME BLADES	Mar 08, 2001	Substantially Equivalent	Oasis Medical, Inc.
K002515	MEDLOGICS ML 4000, MODEL 4000	Feb 22, 2001	Substantially Equivalent	Med-Logics, Inc.
K003143	MILLENNIUM BLADES, MODEL MB101	Dec 11, 2000	Substantially Equivalent	Millennium Biomedical, Inc.
K002849	PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES	Oct 18, 2000	Substantially Equivalent	Surgical Specialties Corp
K001464	DISPOSABLE H-PE MICROKERATOME BLADES	Oct 02, 2000	Substantially Equivalent	Oasis
K001176	DISPOSABLE MICROKERATOME BLADES-PE	Sep 21, 2000	Substantially Equivalent	Oasis Medical, Inc.
K001806	REFRACTIVE SURGERY BLADES	Sep 12, 2000	Substantially Equivalent	Millennium Biomedical, Inc.
K001144	ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS	May 05, 2000	Substantially Equivalent	Lasersight Technologies, Inc.
K993225	BLADEWORKS MICROKERATOME BLADE	Mar 20, 2000	Substantially Equivalent	Blade Works, Inc.
K993122	MSP M/K BLADE	Mar 16, 2000	Substantially Equivalent	Medical Sterile Products, Inc.
K994015	ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508	Mar 15, 2000	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K993190	ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)	Feb 10, 2000	Substantially Equivalent	Surgical Instrument Systems (Sis), Ltd.
K990227	ULTRASHAPER KERATOME	Jan 31, 2000	Substantially Equivalent	Lasersight Technologies, Inc.
K992978	RICROKERATOME BLADE	Nov 16, 1999	Substantially Equivalent	Surgistar, Inc.
K990900	MICROKERATOME, MODEL MK-2000	Sep 24, 1999	Substantially Equivalent	Nidek, Inc.
K984540	KERAVISION VACUUM RING SYSTEM	Apr 28, 1999	Substantially Equivalent	Keravision, Inc.
K981554	MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)	Dec 22, 1998	Substantially Equivalent	Micra Instruments , Ltd.
K980675	SUMMIT KRUMEICH-BARRAQUER MICROKERATOME	Dec 22, 1998	Substantially Equivalent	Summit Technology, Inc.
K983317	BARRON MICROKERATOME SYSTEM, MODEL B2000	Dec 02, 1998	Substantially Equivalent	Barron Precision Instruments, LLC
K981742	ONE UP DISPOSABLE KERATOME HEAD	Aug 25, 1998	Substantially Equivalent	Moria, Inc.
K981155	FLAPMAKER DISPOSABLE MICROKERATOME	Aug 14, 1998	Substantially Equivalent	Hawken Industries
K981071	ML MICROKERATOME	Jul 23, 1998	Substantially Equivalent	Med-Logics, Inc.
K980985	SCMD-1000	May 01, 1998	Substantially Equivalent	Howard Instruments, Inc.
K980510	KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)	May 01, 1998	Substantially Equivalent	Micro Specialties, Inc.
K980508	KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400	May 01, 1998	Substantially Equivalent	Micro Specialties, Inc.
K974598	MICROKERATOME OR THE MATE	Apr 22, 1998	Substantially Equivalent	Howard Instruments, Inc.
K980924	PLANCON MICROLAMELLAR KERATOME EVOLUTION	Apr 15, 1998	Substantially Equivalent	Plancon Instruments
K974004	AUTOMATED DISPOSABLE KERATOME (ADK)	Jan 08, 1998	Substantially Equivalent	Lasersight Technologies, Inc.
K972808	HANSATOME MICROKERATOME	Oct 24, 1997	Substantially Equivalent	Chiron Vision Corp.
K972727	CBALK-1000 BLADE	Oct 10, 1997	Substantially Equivalent	Howard Instruments, Inc.
K973294	INNOVATOME MICROKERATOME	Oct 03, 1997	Substantially Equivalent	Innovative Optics, Inc.
K970377	PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)	Mar 31, 1997	Substantially Equivalent	Plancon Instruments
K962661	ML MICROKERATOME BLADE	Dec 09, 1996	Substantially Equivalent	Med-Logics, Inc.
K960395	PLANCON MIRCOLAMELLAR KERATOME	Apr 26, 1996	Substantially Equivalent	Plancon Instruments
K954058	BARRAQUER-KRUMEICH REFRACTIVE SET	Nov 06, 1995	Substantially Equivalent	Eyetech M.V.A.
K941550	AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT	Nov 22, 1994	Substantially Equivalent	Chiron Vision Corp.
K935342	SCMD KERATOME	Apr 01, 1994	Substantially Equivalent	S.C.M.D. Keratomes of Arizona
K913697	AUTOMATIC CORNEAL SHAPER	Nov 05, 1991	Substantially Equivalent	Hansa Research & Development, Inc.
K911062	QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY	May 22, 1991	Substantially Equivalent	Storz Instrument Co.
K904845	STORZ DRAEGER ROTOR KERATOME	Jan 22, 1991	Substantially Equivalent	Storz Instrument Co.
K903912	KERATOME	Oct 17, 1990	Substantially Equivalent	Micro Precision Instrument Co.
K870807	BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE	May 29, 1987	Substantially Equivalent	Allergan, Inc.
K864065	BKS-42 DISPOSABLE VACUUM TUBING PACK	Dec 15, 1986	Substantially Equivalent	Allergan, Inc.
K860001	BARRAQUER-KRUMEICH REFRACTIVE SET	Feb 04, 1986	Substantially Equivalent	American Medical Optics
K760726	ELECTRO-KERATOTOME, LINE-OPERATED	Oct 05, 1976	Substantially Equivalent	Storz Instrument Co.