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

FDA 510(k) Cleared Refractometer, Ophthalmic Devices (Product Code HKO)

35 devices
1–24 of 35
Cleared Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
K031831
Topcon Medical Systems, Inc.
Ophthalmic · 189d
Cleared May 02, 2000
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K000327
Visx, Incorporated
Ophthalmic · 90d
Cleared May 30, 1995
DIGITAL RETINOSCOPIC PHOTOMETER
K951179
Kudi Kalu, Inc.
Ophthalmic · 75d
Cleared Mar 01, 1995
VIDEO VISION ANALYZER (VIVA), VRB 100
K945959
Tomey Corporation USA
Ophthalmic · 84d
Cleared Sep 02, 1994
AUTO REF-KERATOMETER, RK-3
K942242
Cannon U.S.A., Inc.
Ophthalmic · 116d
Cleared Jul 12, 1994
AUTO REFF-30
K940516
Canon, Inc.
Ophthalmic · 158d
Cleared Feb 17, 1994
AUTOREF LENSMETER RL-10
K925304
Canon USA, Inc.
Ophthalmic · 484d
Cleared Apr 06, 1993
OPTEC 3000
K924741
Stereo Optical Co., Inc.
Ophthalmic · 196d
Cleared Apr 05, 1993
BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8
K924778
R.H. Burton Co.
Ophthalmic · 194d
Cleared Apr 05, 1993
BURTON AUTO REFRACTOR - MODEL BAR-7
K924790
R.H. Burton Co.
Ophthalmic · 194d
Cleared Jan 18, 1991
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
K904828
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
K902500
Nidek, Inc.
Ophthalmic · 52d
Cleared Jun 22, 1990
SHIN NIPPON AUTO REFRACTOMETER QR-007N
K901583
Soderberg, Inc.
Ophthalmic · 79d
Cleared Jun 08, 1990
NIDEK RT-1200S (MARCO TRS-1200)
K901513
Nidek, Inc.
Ophthalmic · 70d
Cleared Feb 27, 1989
NIDEK AR-1200
K890559
Nidek, Inc.
Ophthalmic · 21d
Cleared Aug 18, 1988
CANON AUTOREFRACTOMETER R-22
K883200
Canon USA, Inc.
Ophthalmic · 21d
Cleared Jul 01, 1988
NIDEK ARK-2000
K882191
Nidek, Inc.
Ophthalmic · 38d
Cleared Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
K882287
Canon USA, Inc.
Ophthalmic · 30d
Cleared May 18, 1987
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
K871611
Allergan Humphrey
Ophthalmic · 38d
Cleared Jul 11, 1986
BAUSCH & LOMB GR-3 REFRACTOR
K862521
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
K861065
Nidek, Inc.
Ophthalmic · 20d
Cleared Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
K861062
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
K861066
Nidek, Inc.
Ophthalmic · 15d
Cleared Oct 05, 1984
CANON AUTOREF R-10
K841861
Canon USA, Inc.
Ophthalmic · 154d

About Product Code HKO - Regulatory Context