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HLQ — Keratoscope, Ac-Powered Class I

FDA Device Classification

Classification Details

Product Code
HLQ
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
K003299nidek coOPD-SCAN, MODELS ARK-10000 AND ARK-9000March 9, 2001
K973756eyesys technologiesEYE SYS VISTANovember 13, 1997
K964290reichert ophthalmic instruments, div. leicaEYECHEKJanuary 9, 1997
K945382expertech assocTECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERJanuary 31, 1995
K944207computed anatomyTOPOGRAPHIC MODELING SYSTEM 2 TMS-2December 7, 1994
K944616alliance medical marketinigKERATRON CORNEAL TOPOGRAPHERNovember 22, 1994
K940647orbtekORBSCAN(TM) KERATOMETERJuly 6, 1994
K933556visiopticEH-270 CORNEAL TOPOGRAPHERNovember 2, 1993
K923435par microsystemsCORNEAL TOPOGRAPHY SYSTEMFebruary 16, 1993
K922253luneau ophtalmologieKERATOREF L60June 19, 1992
K912740visionary systemsACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)December 30, 1991
K913022cciCCI VIDEOKERATOSCOPE/COMPARATOROctober 9, 1991
K912130alcon laboratoriesTBD KERATOSCOPEAugust 9, 1991
K895741kera-metricsCLAS PHOTOKERATOSCOPEJuly 11, 1990
K902012computed anatomyVKS-1 VIDEO KERATOSCOPEJune 22, 1990
K901009keraMODEL 2000 INTRAOPERATIVE CORNEASCOPEMay 30, 1990
K901363computed anatomyTOPOGRAPHIC MODELING SYSTEMMay 25, 1990
K895475canon usaCANON AUTO REF-KERATOMETER RK-2October 31, 1989
K890687optimedECT-100 ELECTRONIC CORNEAL TOPOGRAPHERSeptember 5, 1989
K871936canon usaCANON SURGICAL AUTO KERATOMETER SK-1June 19, 1987