Medical Device Manufacturer · US , Fremont , CA

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

16 submissions · 16 cleared · Since 2006

Recent clearances: SOLIX, Avanti, iVue

16
Total
16
Cleared
0
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.

510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant. 5 devices have linked clinical trials registered on ClinicalTrials.gov.

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

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