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KYB — Lens, Guide, Intraocular Class I

FDA Device Classification

Classification Details

Product Code
KYB
Device Class
Class I
Regulation Number
886.4300
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152357staar surgicalMicroSTAAR Injector System CartridgesOctober 30, 2015
K081382duckworth and kentDUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786October 23, 2008
K072985duckworth and kentDUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2June 20, 2008
K070669medicelIOL INJECTOR SETNovember 1, 2007
K063155alcon manufacturingMONARCH III IOL DELIVERY SYSTEMMarch 27, 2007
K063694bausch and lombAKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28March 7, 2007
K032412staar surgicalRE-USEABLE MICROSTAAR INJECTOR, MSI-SJune 10, 2004
K022723mastel precisionMASTEL 1 FOLDER IMPLANTATION SYSTEMDecember 26, 2002
K001157alcon researchMONARCH II IOL DELIVERY SYSTEMJune 27, 2000
K983129staar surgicalDISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)December 4, 1998
K981571alcon laboratoriesMONARCH IOL DELIVERY SYSTEMJuly 9, 1998
K970033alcon laboratoriesMONARCH IOL DELIVERY SYSTEMApril 23, 1997
K965185alcon laboratoriesACRYPAK FOLDERMarch 31, 1997
K961242allerganAMO PHACOFLEX II INTERSECTION SYSTEMJune 17, 1996
K954600staar surgicalMICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)December 21, 1995
K951292chiron visionPASSPORT FOLDABLE LENS PLACEMENT SYSTEMJune 2, 1995
K930628bova intlKLAAS IOL LENSFOLDERFebruary 7, 1995
K940593staar sugicalDISPOSABLE MICROSTAAR INJECTORSeptember 19, 1994
K941603allergan medical opticsAMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECEJuly 6, 1994
K930320allergan medical opticsAMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTRApril 7, 1994