KYB · Class I · 21 CFR 886.4300

FDA Product Code KYB: Lens, Guide, Intraocular

Leading manufacturers include Staar Surgical Co., Alcon Laboratories and Duckworth & Kent, Ltd..

39
Total
39
Cleared
126d
Avg days
1979
Since

FDA 510(k) Cleared Lens, Guide, Intraocular Devices (Product Code KYB)

39 devices
1–24 of 39
Cleared Oct 30, 2015
MicroSTAAR Injector System Cartridges
K152357
STAAR Surgical Company
Ophthalmic · 71d
Cleared Oct 23, 2008
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
K081382
Duckworth & Kent, Ltd.
Ophthalmic · 160d
Cleared Jun 20, 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985
Duckworth & Kent, Ltd.
Ophthalmic · 241d
Cleared Nov 01, 2007
IOL INJECTOR SET
K070669
Medicel AG
Ophthalmic · 234d
Cleared Mar 27, 2007
MONARCH III IOL DELIVERY SYSTEM
K063155
Alcon Manufacturing, Ltd.
Ophthalmic · 161d
Cleared Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412
Staar Surgical Co.
Ophthalmic · 310d
Cleared Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723
Mastel Precision, Inc.
Ophthalmic · 132d
Cleared Jun 27, 2000
MONARCH II IOL DELIVERY SYSTEM
K001157
Alcon Research, Ltd.
Ophthalmic · 78d
Cleared Dec 04, 1998
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129
Staar Surgical Co.
Ophthalmic · 87d
Cleared Jul 09, 1998
MONARCH IOL DELIVERY SYSTEM
K981571
Alcon Laboratories
Ophthalmic · 66d
Cleared Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
K970033
Alcon Laboratories
Ophthalmic · 110d
Cleared Mar 31, 1997
ACRYPAK FOLDER
K965185
Alcon Laboratories
Ophthalmic · 97d
Cleared Jun 17, 1996
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242
Allergan, Inc.
Ophthalmic · 77d
Cleared Dec 21, 1995
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600
Staar Surgical Co.
Ophthalmic · 87d
Cleared Jun 02, 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292
Chiron Vision Corp.
Ophthalmic · 72d
Cleared May 07, 1987
KRATZ NOVA-SERT
K871440
CooperVision, Inc.
Ophthalmic · 24d
Cleared Feb 20, 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jun 17, 1986
SOFT LENS FOLDER
K861990
Staar Surgical Co.
Ophthalmic · 25d
Cleared May 28, 1986
ELASTIC LENS INJECTOR TM
K861085
Staar Surgical Co.
Ophthalmic · 68d
Cleared Mar 21, 1986
MAZZOCCO/FRENCHIK FOLDER
K860148
Staar Surgical Co.
Ophthalmic · 65d
Cleared Jan 22, 1986
IOSERT LENS IMPLANT INSTRUMENT
K854197
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Dec 28, 1982
INTRAOCULAR LENS GUIDE
K823222
American Medical Optics
Ophthalmic · 60d
Cleared Sep 18, 1981
SURFACE REPLACEMENT HIP PROSTHESIS
K811718
Biomet, Inc.
Ophthalmic · 92d

About Product Code KYB - Regulatory Context