FDA 510(k) Applications for Medical Device Product Code "KYF"
(Implant, Eye Valve)

FDA 510(k) Number Applicant Device Name Decision Date
K161457 Allergan, Inc. XEN Glaucoma Treatment System 11/21/2016
K220032 Glaukos Corporation iStent infinite Trabecular Micro-Bypass System, Model iS3 08/02/2022
K152996 INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) Molteno3 Glaucoma Implant 12/17/2015
K062252 IOP, INC. MOLTENO3 09/27/2006
K182518 New World Medical, Inc. AHMED ClearPath Glaucoma Drainage Device 01/18/2019
K162060 NEW WORLD MEDICAL, INC. Ahmed Glaucoma Valve 10/24/2016
K991072 NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE IMPLANT 07/13/1999
K171451 New World Medical, Inc. Ahmed Glaucoma Valve Model FP8 08/08/2017
K060644 NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE, MODEL M4 09/18/2006
K980657 NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE, MODEL S3 04/20/1998
K230975 New World Medical, Inc. Ahmed« Glaucoma Valve Model FP7 05/12/2023
K231051 New World Medical, Inc. Ahmed« Glaucoma Valve Model FP8 05/12/2023
K012852 OPTONOL, LTD EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS 03/26/2002
K030350 OPTONOL, LTD EXPRESS MINI GLAUCOMA SHUNT 03/13/2003
K955455 PHARMACIA IOVISION, INC. BAERVELT PARS PLANA GLAUCOMA IMPLANT 02/18/1997


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