FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K162783 |
Bioptigen, Inc. |
EnFocus 2300, EnFocus 4400 |
12/09/2016 |
K182942 |
Canon Inc. |
Canon OCT-A1 |
07/24/2019 |
K133217 |
CARL ZEISS MEDITEC AG |
CIRRUS PHOTO |
03/19/2014 |
K141844 |
CARL ZEISS MEDITEC AG |
RESCAN 700, CALLISTO EYE |
11/18/2014 |
K180229 |
Carl Zeiss Meditec AG |
RESCAN 700, CALLISTO eye |
01/11/2019 |
K150977 |
CARL ZEISS MEDITEC INC |
CIRRUS HD-OCT |
09/01/2015 |
K222200 |
Carl Zeiss Meditec Inc |
CIRRUS HD-OCT |
04/13/2023 |
K083291 |
CARL ZEISS MEDITEC INC |
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 |
05/05/2009 |
K111157 |
CARL ZEISS MEDITEC INC |
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES |
01/19/2012 |
K112184 |
CARL ZEISS MEDITEC INC |
CIRRUS PHOTO |
06/18/2012 |
K181534 |
Carl Zeiss Meditec, Inc. |
CIRRUS HD-OCT |
02/15/2019 |
K161194 |
CARL ZEISS MEDITEC, INC. |
PLEX Elite 9000 SS-OCT |
10/26/2016 |
K163195 |
Carl Zeiss Suzhou Co., Ltd. |
PRIMUS |
06/21/2017 |
K063191 |
HEIDELBERG ENGINEERING |
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT |
10/31/2006 |
K101223 |
HEIDELBERG ENGINEERING |
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA |
10/01/2010 |
K211817 |
Heidelberg Engineering GmbH |
Anterion |
11/05/2021 |
K113129 |
HEIDELBERG ENGINEERING GMBH |
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
11/08/2011 |
K173648 |
Heidelberg Engineering GmbH |
Spectralis HRA + OCT and variants |
08/30/2018 |
K152205 |
Heidelberg Engineering GmbH |
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor |
05/06/2016 |
K121993 |
HEIDELBERG ENGINEERING GMBH |
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
10/25/2012 |
K172649 |
Heidelberg Engineering GmbH |
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor |
11/01/2017 |
K192391 |
Heidelberg Engineering GmbH |
Spectralis HRA+OCT and Variants |
09/26/2019 |
K201252 |
Heidelberg Engineering GmbH |
Spectralis HRA+OCT and variants |
09/09/2020 |
K182569 |
Heidelberg Engineering GmbH |
Spectralis HRA+OCT and variants with High Magnification Module |
10/18/2018 |
K181594 |
Heidelberg Engineering GmbH |
Spectralis HRA+OCT and variants with OCT Angiography Module |
09/13/2018 |
K121622 |
NIDEK CO., LTD. |
NIDEK RS-3000 |
03/14/2013 |
K132323 |
NIDEK CO., LTD. |
RS-3000 ADVANCE |
02/19/2014 |
K221320 |
Nidek Co., LTD. |
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX |
03/30/2023 |
K080460 |
OPKO HEALTH, INC. |
SPECTRAL OCT/SLO |
11/14/2008 |
K200516 |
OptoMedical Technologies GmbH |
OCT-Camera ID 21101A3 |
09/02/2020 |
K121043 |
OPTOS PLC |
OPTOS OCT/SLO MICROPERIMETER |
02/22/2013 |
K173707 |
Optos plc |
P200TE |
02/28/2018 |
K231673 |
Optos Plc |
P200TE (A10700) |
08/18/2023 |
K190732 |
Optos Plc |
P200TxE |
07/31/2019 |
K180660 |
Optovue, Inc. |
Avanti |
06/08/2018 |
K071250 |
OPTOVUE, INC. |
CA, MODEL: CAM |
09/28/2007 |
K163475 |
Optovue, Inc. |
iVue |
06/09/2017 |
K091404 |
OPTOVUE, INC. |
IVUE, MODEL 100 |
04/22/2010 |
K062552 |
OPTOVUE, INC. |
RTVUE |
10/06/2006 |
K111505 |
OPTOVUE, INC. |
RTVUE CAM WITH CORNEAL POWER UPGRADE |
09/08/2011 |
K222166 |
Optovue, Inc. |
SOLIX |
11/09/2022 |
K071839 |
REICHERT, INC. |
SOCT COPERNICUS, MODEL 15205 |
02/27/2008 |
K213265 |
Tomey Corporation |
Tomey Cornea/Anterior Segment OCT CASIA2 |
04/27/2022 |
K092470 |
TOPCON CORP. |
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 |
09/02/2009 |
K063388 |
TOPCON CORP. |
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
06/22/2007 |
K161509 |
Topcon Corporation |
3D OCT-1 Maestro |
07/28/2016 |
K170164 |
Topcon Corporation |
3D OCT-1 Maestro |
03/03/2017 |
K173119 |
Topcon Corporation |
DRI OCT Triton |
01/19/2018 |
K083316 |
TOPCON MEDICAL SYSTEMS, INC. |
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
03/13/2009 |
K072971 |
TOPCON MEDICAL SYSTEMS, INC. |
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS |
01/13/2009 |