Medical Device Manufacturer · US , Fremont , CA

Optovue, Inc.

16 submissions · 16 cleared · Since 2006
16
Total
16
Cleared
0
Denied

Optovue, Inc. — FDA 510(k) Submissions

Optovue, Inc. has submitted 16 FDA 510(k) premarket notifications since 2006, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tomography, Optical Coherence, Ophthalmoscope, Ac-powered, Camera, Ophthalmic, Ac-powered . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
SOLIX
K222166 · OBO Tomography, Optical... · Ophthalmic
Nov 2022 111d
Avanti
K180660 · OBO Tomography, Optical... · Ophthalmic
Jun 2018 86d
iVue
K163475 · OBO Tomography, Optical... · Ophthalmic
Jun 2017 179d
RTVue XR OCT Avanti with AngioVue Software
K153080 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Feb 2016 111d
IVUE 500
K133892 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Mar 2014 89d
IFUSION
K130656 · HKI Camera, Ophthalmic,... · Ophthalmic
Jul 2013 113d
IVUE WITH NORMATIVE DATABASE
K121739 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jan 2013 219d
ICAM FUNDUS CAMERA
K122572 · HKI Camera, Ophthalmic,... · Ophthalmic
Jan 2013 141d
RTVUE XR OCT
K120238 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Apr 2012 68d
RTVUE CAM WITH CORNEAL POWER UPGRADE
K111505 · OBO Tomography, Optical... · Ophthalmic
Sep 2011 100d
ISTAND
K103266 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jun 2011 211d
RTVUE MODEL RTVUE 100
K101505 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Sep 2010 106d
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jun 2010 83d
IVUE, MODEL 100
K091404 · OBO Tomography, Optical... · Ophthalmic
Apr 2010 345d
CA, MODEL: CAM
K071250 · OBO Tomography, Optical... · Ophthalmic
Sep 2007 147d
RTVUE
K062552 · OBO Tomography, Optical... · Ophthalmic
Oct 2006 37d
Filters
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