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HMY — Keratome, Battery-Powered Class I

FDA Device Classification

Classification Details

Product Code
HMY
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
K040297moriaONEUSE- PLUS MICROKERATOMEMarch 31, 2004
K023092becton, dickinson andBD K-4000 MICROKERATOME SYSTEMOctober 18, 2002
K022637becton, dickinson andBD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOMEOctober 16, 2002
K022560moriaM2 SINGLE USE MICROKERTOMESeptember 27, 2002
K003594moriaCARRIAZO BARRAQUER SINGLE USE MICROKERATOMEMarch 9, 2001
K002191moriaCARRIAZO BARRAQUER II MICROKERATOMEOctober 12, 2000
K992687industrial and medical designMILLENIUM MICROKERATOME, MODEL IMD-001September 24, 1999
K984537insight technologies instrumentsKERATOME SYSTEM, MODEL K3000May 14, 1999
K981741moriaCARRIAZO BARRAQUER MICROKERATOMEJuly 24, 1998
K974243insight technologies instrumentsKERATOME SYSTEMJanuary 20, 1998
K902857visitecVISI-DRAPE OPHTHALMIC DRAPESJuly 31, 1990
K781412codman and shurtleffOSCILLATING KNIFE AND ACCESSORIESOctober 11, 1978