HLQ · Class I · 21 CFR 886.1350

FDA Product Code HLQ: Keratoscope, Ac-powered

Leading manufacturers include Nidek, Inc., Canon USA, Inc. and Eyesys Technologies, Inc..

29
Total
29
Cleared
91d
Avg days
1979
Since

FDA 510(k) Cleared Keratoscope, Ac-powered Devices (Product Code HLQ)

29 devices
1–24 of 29
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299
Nidek Co., Ltd.
Ophthalmic · 140d
Cleared Nov 13, 1997
EYE SYS VISTA
K973756
Eyesys Technologies, Inc.
Ophthalmic · 42d
Cleared Jan 09, 1997
EYECHEK
K964290
Reichert Ophthalmic Instruments, Div. Leica, Inc.
Ophthalmic · 73d
Cleared Aug 09, 1991
TBD KERATOSCOPE
K912130
Alcon Laboratories
Ophthalmic · 87d
Cleared Oct 31, 1989
CANON AUTO REF-KERATOMETER RK-2
K895475
Canon USA, Inc.
Ophthalmic · 50d
Cleared Jun 19, 1987
CANON SURGICAL AUTO KERATOMETER SK-1
K871936
Canon USA, Inc.
Ophthalmic · 32d
Cleared Jul 23, 1986
NIDEK KM-1000 SURGICAL KERATOMETER
K862137
Nidek, Inc.
Ophthalmic · 49d
Cleared Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
K861063
Nidek, Inc.
Ophthalmic · 15d
Cleared Oct 15, 1985
ZEISS OPERATING KERATOMETER
K853723
Carl Zeiss, Inc.
Ophthalmic · 40d
Cleared Aug 07, 1984
WOODLYN STANDARD SLIT LAMP HSSL-ST
K841765
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Jun 30, 1983
SUN PHOTO-KERATOSCOPE
K831084
Nidek, Inc.
Ophthalmic · 87d

About Product Code HLQ - Regulatory Context