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HLR — Keratoscope, Battery-Powered Class I

FDA Device Classification

Classification Details

Product Code
HLR
Device Class
Class I
Regulation Number
886.1350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K901553sanbornSURG-K SURGICAL KERATOMETERJuly 20, 1990
K882902technitexQRK 100, QUALITATIVE RING KERATOSCOPEAugust 4, 1988
K882618gamut entJEDMED/POLACK KERATOSCOPE HS/SLJuly 13, 1988
K864639jedmed instrumentREUSABLE SURGICAL KERATOSCOPEDecember 29, 1986
K854054cutler medical instrumentsPLACIDO DISCDecember 27, 1985
K830008surgidevKARICKHOFF KERATOSCOPEJanuary 26, 1983
K821080medical equipment designsHAND KERATOSCOPEMay 24, 1982