Product Code: KYB FDA class 1 21 CFR 886.4300

Lens, Guide, Intraocular

Ophthalmic

The Intraocular Lens Guide is an ophthalmic device used to assist in the precise insertion and positioning of an intraocular lens into the eye during cataract surgery or lens replacement procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYB, regulated under 21 CFR 886.4300, in the Ophthalmic medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: KYB
Device Class: FDA class 1
Regulation Number: 886.4300
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

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 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K152357	MicroSTAAR Injector System Cartridges	Oct 30, 2015	Substantially Equivalent	STAAR Surgical Company
K081382	DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786	Oct 23, 2008	Substantially Equivalent	Duckworth & Kent, Ltd.
K072985	DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2	Jun 20, 2008	Substantially Equivalent	Duckworth & Kent, Ltd.
K070669	IOL INJECTOR SET	Nov 01, 2007	Substantially Equivalent	Medicel AG
K063155	MONARCH III IOL DELIVERY SYSTEM	Mar 27, 2007	Substantially Equivalent	Alcon Manufacturing, Ltd.
K063694	AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28	Mar 07, 2007	Substantially Equivalent	Bausch & Lomb, Inc.
K032412	RE-USEABLE MICROSTAAR INJECTOR, MSI-S	Jun 10, 2004	Substantially Equivalent	Staar Surgical Co.
K022723	MASTEL 1 FOLDER IMPLANTATION SYSTEM	Dec 26, 2002	Substantially Equivalent	Mastel Precision, Inc.
K001157	MONARCH II IOL DELIVERY SYSTEM	Jun 27, 2000	Substantially Equivalent	Alcon Research, Ltd.
K983129	DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)	Dec 04, 1998	Substantially Equivalent	Staar Surgical Co.
K981571	MONARCH IOL DELIVERY SYSTEM	Jul 09, 1998	Substantially Equivalent	Alcon Laboratories
K970033	MONARCH IOL DELIVERY SYSTEM	Apr 23, 1997	Substantially Equivalent	Alcon Laboratories
K965185	ACRYPAK FOLDER	Mar 31, 1997	Substantially Equivalent	Alcon Laboratories
K961242	AMO PHACOFLEX II INTERSECTION SYSTEM	Jun 17, 1996	Substantially Equivalent	Allergan, Inc.
K954600	MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)	Dec 21, 1995	Substantially Equivalent	Staar Surgical Co.
K951292	PASSPORT FOLDABLE LENS PLACEMENT SYSTEM	Jun 02, 1995	Substantially Equivalent	Chiron Vision Corp.
K930628	KLAAS IOL LENSFOLDER	Feb 07, 1995	Substantially Equivalent	Bova Intl.
K940593	DISPOSABLE MICROSTAAR INJECTOR	Sep 19, 1994	Substantially Equivalent	Staar Sugical
K941603	AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE	Jul 06, 1994	Substantially Equivalent	Allergan Medical Optics
K930320	AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR	Apr 07, 1994	Substantially Equivalent	Allergan Medical Optics
K903575	CHIROFLEX FORCEPS	Dec 21, 1990	Substantially Equivalent	Chiron Ophthalmics
K903574	CHIROFLEX LENS MICROSERT	Sep 17, 1990	Substantially Equivalent	Chiron Ophthalmics
K883489	KRATZ NOVA SERT(TM)	Oct 25, 1988	Substantially Equivalent	Coopervision-Cilco
K871440	KRATZ NOVA-SERT	May 07, 1987	Substantially Equivalent	CooperVision, Inc.
K870265	KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR	Feb 20, 1987	Substantially Equivalent	CooperVision, Inc.
K861990	SOFT LENS FOLDER	Jun 17, 1986	Substantially Equivalent	Staar Surgical Co.
K861085	ELASTIC LENS INJECTOR TM	May 28, 1986	Substantially Equivalent	Staar Surgical Co.
K860148	MAZZOCCO/FRENCHIK FOLDER	Mar 21, 1986	Substantially Equivalent	Staar Surgical Co.
K854994	BARTELL SMALL INCISION LENS GLIDE	Feb 04, 1986	Substantially Equivalent	Microtech, Inc.
K854197	IOSERT LENS IMPLANT INSTRUMENT	Jan 22, 1986	Substantially Equivalent	Chiron Vision Corp.
K841730	BAILEY LENS SHOOTER	Nov 19, 1984	Substantially Equivalent	Intermedics Intraocular, Inc.
K840694	LENS INSERTION GLIDE	May 09, 1984	Substantially Equivalent	Innovative Surgical Products, Inc.
K840104	PETRUS IOL GUIDE	Apr 24, 1984	Substantially Equivalent	Precision-Cosmet Co., Inc.
K832939	I-GLIDE IOL IMPLANTATION AID	Oct 04, 1983	Substantially Equivalent	I For M, Inc.
K823222	INTRAOCULAR LENS GUIDE	Dec 28, 1982	Substantially Equivalent	American Medical Optics
K821381	IOL FORCEPS	Jun 14, 1982	Substantially Equivalent	Cilco, Inc.
K811718	SURFACE REPLACEMENT HIP PROSTHESIS	Sep 18, 1981	Substantially Equivalent	Biomet, Inc.
K792066	M.P.I. LENS GLIDE	Jan 29, 1980	Substantially Equivalent	J. Leon Bilby
K791351	CEMENT SPACERS	Aug 03, 1979	Substantially Equivalent	Depuy, Inc.