HJO · Class II · 21 CFR 886.1850

FDA Product Code HJO: Biomicroscope, Slit-lamp, Ac-powered

Leading manufacturers include Carl Zeiss Meditec, AG, Carl Zeiss, Inc. and Bausch & Lomb, Inc..

109
Total
109
Cleared
126d
Avg days
1980
Since
109 devices
73–96 of 109
Cleared Jun 15, 1995
NEITZ SLIT LAMP SL-H2
K951341
Neitz Instruments Company, Ltd.
Ophthalmic · 83d
Cleared May 12, 1995
OTI MODEL 78-60
K951184
Oti Medical, LLC
Ophthalmic · 57d
Cleared Apr 10, 1995
NEITZ SLIT LAMP SL-H1
K951340
Neitz Instruments Company, Ltd.
Ophthalmic · 17d
Cleared Mar 22, 1995
XCEL SLIT LAMP
K951054
Leica, Inc.
Ophthalmic · 15d
Cleared Nov 22, 1994
TOMEY EM-1000 SPECULAR MICROSCOPE
K944910
Tomey Corporation USA
Ophthalmic · 48d
Cleared Apr 01, 1994
SLIT LAMP, H-201
K936209
Canon USA, Inc.
Ophthalmic · 93d
Cleared Jan 25, 1994
TALIA LASER SLIT
K930518
Talia Technology , Ltd.
Ophthalmic · 358d
Cleared Sep 09, 1993
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641
Carl Zeiss, Inc.
Ophthalmic · 304d
Cleared Aug 09, 1993
MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS
K930438
Marco Ophthalmic, Inc.
Ophthalmic · 195d
Cleared Apr 14, 1993
BURTON SLIT LAMP - MODEL 850
K924783
R.H. Burton Co.
Ophthalmic · 203d
Cleared Jan 27, 1993
BURTON HAND HELD SLIT LAMP - MODEL SL750
K924770
R.H. Burton Co.
Ophthalmic · 126d
Cleared Jan 27, 1993
BURTON SLIT LAMP - MODEL 2000
K924782
R.H. Burton Co.
Ophthalmic · 126d
Cleared Jan 27, 1993
BURTON SLIT LAMP
K924787
R.H. Burton Co.
Ophthalmic · 126d
Cleared Feb 21, 1992
OPACITRAC
K915356
Oculon Corp.
Ophthalmic · 87d
Cleared Feb 07, 1992
LASER FLARE METER
K913852
Kowa Optimed, Inc.
Ophthalmic · 164d
Cleared Dec 16, 1991
TANDEM SCANNING MICROSCOPE
K912514
Tandem Scanning Corp.
Ophthalmic · 193d
Cleared May 22, 1991
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K910980
Site Microsurgical Systems, Inc.
Ophthalmic · 76d
Cleared Feb 21, 1990
WOODLYN SLIT LAMP MODEL HR-1
K900476
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Feb 21, 1990
WOODLYN CLASSIC SLIT LAMP MODEL SMM
K900477
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Sep 27, 1988
LASER FLARE CELL METER FC-1000
K880920
Kowa Optimed, Inc.
Ophthalmic · 207d
Cleared Jan 27, 1988
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160
Carl Zeiss, Inc.
Ophthalmic · 106d
Cleared Dec 23, 1987
OCS 100 (OCULAR COMPARATOR SYSTEM)
K874220
Ocular Instruments, Inc.
Ophthalmic · 68d
Cleared Dec 29, 1986
MLC ENDOTHELIAL CELL COUNTER
K863970
Mlc Technologies
Ophthalmic · 76d
Cleared Sep 03, 1986
OPM SLIT LAMP MODEL P-1 & MODEL P-3
K863048
Optek Medico Co., Ltd.
Ophthalmic · 22d