KYB · Class I · 21 CFR 886.4300

FDA Product Code KYB: Lens, Guide, Intraocular

Leading manufacturers include Alcon Laboratories, Chiron Vision Corp. and CooperVision, Inc..

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 Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694
Bausch & Lomb, Inc.
Ophthalmic · 84d
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 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 Jan 22, 1986
IOSERT LENS IMPLANT INSTRUMENT
K854197
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Sep 18, 1981
SURFACE REPLACEMENT HIP PROSTHESIS
K811718
Biomet, Inc.
Ophthalmic · 92d
Cleared Aug 03, 1979
CEMENT SPACERS
K791351
Depuy, Inc.
Ophthalmic · 17d

About Product Code KYB - Regulatory Context