HKO — Refractometer, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HKO
Device Class
Class I
Regulation Number
886.1760
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K031831topcon medical systemsTOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMDecember 19, 2003
K000327visx, incorporatedWAVESCAN WAVEFRONT SYSTEM MODEL HS 1May 2, 2000
K951179kudi kaluDIGITAL RETINOSCOPIC PHOTOMETERMay 30, 1995
K945959tomey corporation usaVIDEO VISION ANALYZER (VIVA), VRB 100March 1, 1995
K942242cannon u.s.aAUTO REF-KERATOMETER, RK-3September 2, 1994
K940516canonAUTO REFF-30July 12, 1994
K925304canon usaAUTOREF LENSMETER RL-10February 17, 1994
K924741stereo optical coOPTEC 3000April 6, 1993
K924790r.h. burtonBURTON AUTO REFRACTOR - MODEL BAR-7April 5, 1993
K924778r.h. burtonBURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8April 5, 1993
K904828stereo optical coOPTEC 2300 AFVT, ARMED FORCES VISION TESTERJanuary 18, 1991
K902500nidekAR-1600G AUTO-REFRACTOMETERJuly 27, 1990
K901583soderbergSHIN NIPPON AUTO REFRACTOMETER QR-007NJune 22, 1990
K901513nidekNIDEK RT-1200S (MARCO TRS-1200)June 8, 1990
K890559nidekNIDEK AR-1200February 27, 1989
K883200canon usaCANON AUTOREFRACTOMETER R-22August 18, 1988
K882191nidekNIDEK ARK-2000July 1, 1988
K882287canon usaCANON AUTOREFRACTOMETER R-20July 1, 1988
K871611allergan humphreyALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540May 18, 1987
K862521bausch and lombBAUSCH & LOMB GR-3 REFRACTORJuly 11, 1986