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HNO — Keratome, Ac-Powered Class I

FDA Device Classification

Classification Details

Product Code
HNO
Device Class
Class I
Regulation Number
886.4370
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K173371carl zeiss meditecVisuMax Femtosecond LaserApril 13, 2018
K172994moriaEPI K ConsoleOctober 26, 2017
K072102gebauer medizintechnikEPIVISION SL SYSTEMJanuary 16, 2009
K082043schwind eye-tech-solutions gmbh and co. kgCARRIAZO-PENDULAR MICROKERATOMEAugust 1, 2008
K062465bausch and lombZYOPTIX XP EPI SEPARATOR SYSTEMSeptember 6, 2006
K052891hawken industriesHORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMMarch 23, 2006
K051486norwood abbeyNORWOOD ABBEY CENTURION SES EPIKERATOMEJuly 6, 2005
K043183moriaEPI-KMarch 25, 2005
K043150sis ltd., surgical instrument systemsAMADEUS II EPIKERATOMEJanuary 31, 2005
K042083biovisionMODIFICATION TO VISITOME 20-10 MICROKERATOMENovember 16, 2004
K042810norwood abbeyCENTURION SES EPIKERATOMEOctober 28, 2004
K041110millennium biomedicalMB 105 MILLENNIUM BLADESOctober 13, 2004
K041206gebauer medizintechnikEPITOME SYSTEMSeptember 15, 2004
K032910schwind eye-tech-solutions gmbh and co. kgCARRIAZO PENDULARAugust 30, 2004
K032836moriaM3 MICROKERATOMEJune 18, 2004
K033457micro specialtiesM2 COMPATIBLE MICROKERATOME BLADEMay 25, 2004
K033236surgin surgical instrumentationPRIZM KERATOME BLADE, MODEL MK8512M2March 26, 2004
K040204bausch and lombZYOPTIX XP MICROKERATOMEMarch 22, 2004
K033182surgin surgical instrumentationPRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDJanuary 30, 2004
K033293med-logicsMED-LOGICS, MODEL ML7090January 13, 2004