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HMY — Keratome, Battery-Powered Class I

FDA Device Classification

FDA product code HMY covers "Keratome, Battery-Powered", a Class I medical device regulated under 21 CFR 886.4370. Submissions are reviewed by the Ophthalmic panel. At least 12 recent 510(k) clearances have been granted under this product code.

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

FDA data resources