Medical Device Manufacturer · US , Fremont , CA

Optovue, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2006

Recent clearances: SOLIX, Avanti

Total

Cleared

Denied

Optovue, Inc. has 16 FDA 510(k) cleared ophthalmic devices. Based in Fremont, US.

Last cleared in 2022. Active since 2006.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

2 devices have linked clinical trials registered on ClinicalTrials.gov.

Optovue, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Optovue, Inc.

16 devices

1-16 of 16

Cleared CT Nov 09, 2022

SOLIX

K222166 · OBO

Ophthalmic · 111d

Cleared CT Jun 08, 2018

RTVue XR OCT Avanti with AngioVue Software

IVUE WITH NORMATIVE DATABASE

RTVUE CAM WITH CORNEAL POWER UPGRADE

RTVUE MODEL RTVUE 100

K101505 · HLI

Ophthalmic · 106d

Cleared Jun 17, 2010

R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 17, 2026

Optovue, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Optovue, Inc.

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