HKO · Class I · 21 CFR 886.1760

FDA Product Code HKO: Refractometer, Ophthalmic

Leading manufacturers include Nidek, Inc., Canon USA, Inc. and Stereo Optical Co., Inc..

35
Total
35
Cleared
95d
Avg days
1977
Since
35 devices
25–35 of 35
Cleared Oct 05, 1984
VISION TESTER
K843042
Stereo Optical Co., Inc.
Ophthalmic · 64d
Cleared Jun 10, 1983
AUTO REFRACTOMETER
K831083
Nidek, Inc.
Ophthalmic · 67d
Cleared Jun 25, 1982
AUTOMATIC OBJECTIVE REFRACTOR 2000
K820877
Dicon, Inc.
Ophthalmic · 87d
Cleared Dec 02, 1981
I.V.E. REFRACTION SYSTEM
K812896
Bausch & Lomb, Inc.
Ophthalmic · 48d
Cleared Aug 18, 1981
SR-1V DATA PRINTER
K812063
American Optical Corp.
Ophthalmic · 28d
Cleared Apr 23, 1981
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
K802183
American Optical Corp.
Ophthalmic · 226d
Cleared Apr 23, 1981
AUTO REFRACTOMETER NR-1000
K802958
Nippon Kogaku, Inc.
Chemistry · 154d
Cleared Nov 12, 1980
OBJECTIVE REFRACTOR
K802029
Zeiss Humphrey System
Ophthalmic · 83d
Cleared Aug 27, 1980
DIOPTRON III AUTOREFRACTOR
K801906
Coherent Medical Division
Ophthalmic · 16d
Cleared Sep 07, 1978
AUTOREFRACTOR, SUBJECTIVE
K781014
Cavitron Corp.
Ophthalmic · 83d
Cleared Nov 09, 1977
SUBJECTIVE REFRACTOR, MOSEL SR-111
K771914
American Optical Corp.
Ophthalmic · 28d