Product Code: HMY FDA class 1 21 CFR 886.4370

Keratome, Battery-Powered

Ophthalmic

The Battery-Powered Keratome is a portable, battery-operated surgical instrument used to make precise incisions in the cornea during ophthalmic procedures such as cataract surgery or corneal transplantation. It is classified as FDA Class 1, the lowest risk category, and requires 510(k) premarket notification before marketing, demonstrating substantial equivalence to a predicate device. The product code is HMY, regulated under 21 CFR 886.4370, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

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510(k)s

FEI Numbers

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Basic Information

Product Code: HMY
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 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K040297	ONEUSE- PLUS MICROKERATOME	Mar 31, 2004	Substantially Equivalent	Moria SA
K023092	BD K-4000 MICROKERATOME SYSTEM	Oct 18, 2002	Substantially Equivalent	Becton, Dickinson & CO
K022637	BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME	Oct 16, 2002	Substantially Equivalent	Becton, Dickinson & CO
K022560	M2 SINGLE USE MICROKERTOME	Sep 27, 2002	Substantially Equivalent	Moria SA
K003594	CARRIAZO BARRAQUER SINGLE USE MICROKERATOME	Mar 09, 2001	Substantially Equivalent	Moria, Inc.
K002191	CARRIAZO BARRAQUER II MICROKERATOME	Oct 12, 2000	Substantially Equivalent	Moria, Inc.
K992687	MILLENIUM MICROKERATOME, MODEL IMD-001	Sep 24, 1999	Substantially Equivalent	Industrial & Medical Design, Inc.
K984537	KERATOME SYSTEM, MODEL K3000	May 14, 1999	Substantially Equivalent	Insight Technologies Instruments, LLC
K981741	CARRIAZO BARRAQUER MICROKERATOME	Jul 24, 1998	Substantially Equivalent	Moria, Inc.
K974243	KERATOME SYSTEM	Jan 20, 1998	Substantially Equivalent	Insight Technologies Instruments, LLC
K902857	VISI-DRAPE OPHTHALMIC DRAPES	Jul 31, 1990	Substantially Equivalent	Visitec Co.
K781412	OSCILLATING KNIFE AND ACCESSORIES	Oct 11, 1978	Substantially Equivalent	Codman & Shurtleff, Inc.