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KYF — Implant, Eye Valve Class II

FDA Device Classification

Classification Details

Product Code
KYF
Device Class
Class II
Regulation Number
886.3920
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230975new world medicalAhmed® Glaucoma Valve Model FP7May 12, 2023
K231051new world medicalAhmed® Glaucoma Valve Model FP8May 12, 2023
K220032glaukos corporationiStent infinite Trabecular Micro-Bypass System, Model iS3August 2, 2022
K182518new world medicalAHMED ClearPath Glaucoma Drainage DeviceJanuary 18, 2019
K171451new world medicalAhmed Glaucoma Valve Model FP8August 8, 2017
K161457allerganXEN Glaucoma Treatment SystemNovember 21, 2016
K162060new world medicalAhmed Glaucoma ValveOctober 24, 2016
K152996innovative ophthalmic products, inc. (iop)Molteno3 Glaucoma ImplantDecember 17, 2015
K062252iopMOLTENO3September 27, 2006
K060644new world medicalAHMED GLAUCOMA VALVE, MODEL M4September 18, 2006
K030350optonolEXPRESS MINI GLAUCOMA SHUNTMarch 13, 2003
K012852optonolEX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONSMarch 26, 2002
K991072new world medicalAHMED GLAUCOMA VALVE IMPLANTJuly 13, 1999
K980657new world medicalAHMED GLAUCOMA VALVE, MODEL S3April 20, 1998
K955455pharmacia iovisionBAERVELT PARS PLANA GLAUCOMA IMPLANTFebruary 18, 1997
K925636new world medicalAHMED GLAUCOMA VALVE IMPLANTNovember 12, 1993
K905703hood laboratoriesKRUPIN EYE VALVE WITH DISKMarch 15, 1991
K902296visionexTRABECULO-SUPRACHOROIDAL SHUNTMarch 14, 1991
K905129wright medicalBAERVELDT GLAUCOMA IMPLANTFebruary 11, 1991
K903462optimedOPTIMED GLAUCOMA PRESSURE REGULATOROctober 16, 1990