HLI · Class II · 21 CFR 886.1570

FDA Product Code HLI: Ophthalmoscope, Ac-powered

Leading manufacturers include Optovue, Inc., Neitz Instruments Company, Ltd. and Carl Zeiss Meditec, Inc..

87
Total
87
Cleared
105d
Avg days
1977
Since

FDA 510(k) Cleared Ophthalmoscope, Ac-powered Devices (Product Code HLI)

87 devices
1–24 of 87
Cleared Feb 11, 2016
RTVue XR OCT Avanti with AngioVue Software
K153080
Optovue, Inc.
Ophthalmic · 111d
Cleared Dec 02, 2015
EnFocus 2300, EnFocus 4400
K150722
Bioptigen, Inc.
Ophthalmic · 257d
Cleared Mar 04, 2015
OCT-Camera
K142953
Optomedical Technologies GmbH
Ophthalmic · 145d
Cleared Sep 17, 2014
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638
Propper Manufacturing Co., Inc.
Ophthalmic · 90d
Cleared Apr 23, 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758
Centervue S.P.A.
Ophthalmic · 133d
Cleared Mar 26, 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939
Amico Diagnostic Incorporated
Ophthalmic · 272d
Cleared Mar 19, 2014
IVUE 500
K133892
Optovue, Inc.
Ophthalmic · 89d
Cleared Feb 26, 2013
HEINE OMEGA 500
K123316
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 124d
Cleared Jan 18, 2013
IVUE WITH NORMATIVE DATABASE
K121739
Optovue, Inc.
Ophthalmic · 219d
Cleared May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057
Bioptigen, Inc.
Ophthalmic · 123d
Cleared Apr 03, 2012
RTVUE XR OCT
K120238
Optovue, Inc.
Ophthalmic · 68d
Cleared Jul 08, 2011
RHA2020
K111531
Annidis Health Systems Corp.
Ophthalmic · 36d
Cleared Jun 03, 2011
ISTAND
K103266
Optovue, Inc.
Ophthalmic · 211d
Cleared Feb 09, 2011
AAIO-7, AAIO WIRLESS
K110205
Appasamy Associates
Ophthalmic · 15d
Cleared Sep 15, 2010
RTVUE MODEL RTVUE 100
K101505
Optovue, Inc.
Ophthalmic · 106d
Cleared Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861
Optovue, Inc.
Ophthalmic · 83d
Cleared Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
K063378
Carl Zeiss Meditec, Inc.
Ophthalmic · 79d
Cleared May 23, 2006
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Sep 30, 2005
VISANTE OCT
K051789
Carl Zeiss Meditec, Inc.
Ophthalmic · 91d
Cleared Jan 21, 2005
OCT-OPTHALMOSCOPE
K042885
Ophthalmic Technologies, Inc.
Ophthalmic · 94d
Cleared Oct 07, 2004
PANORAMIC 200A
K042001
Optos Plc.
Ophthalmic · 73d
Cleared May 24, 2004
RTA MODEL D RETINAL THICKNESS ANALYZER
K041290
Talia Technology , Ltd.
Ophthalmic · 11d
Cleared Apr 20, 2004
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
K033123
Carl Zeiss Meditec, Inc.
Radiology · 203d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433
Carl Zeiss Meditec, Inc.
Ophthalmic · 80d

About Product Code HLI - Regulatory Context