Optovue, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000018369 FEI 3005950902

Optovue, Inc. is a medical device manufacturer based in the United States, with 86 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) and 9 FDA recalls as of 14 Nov 2026.

Devices: 86
Registrations: EUDAMEDFDA
FDA recalls: 9

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries: FDA GUDID 69
FDA 510(k) 16
EUDAMED 3

A device listed in two registries counts in both.
Device classes: FDA Class II 85
EU Class IIa 1
Top EMDN categories: Instruments for functional explorations and therapeutic interventions 1
FDA recalls: 9 recalls matched by name
Identifiers: EUDAMED SRN US-MF-000018369
FDA FEI 3005950902
DUNS 196500461

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union: EUDAMED actor, 1 certificate
United States: FDA FEI, FDA recalls

Catalogue86

Newest first, rows 1-50 of 86

Search and filter all 86 devices

Rows 1-50 of 86

Showing 1-50 of 86

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN: US-MF-000018369
FDA FEI number: 3005950902
DUNS number: 196500461
EUDAMED status: Active
EUDAMED registered name: Optovue, Inc.
Registered address: 231, Charcot Avenue, 95131, San Jose, United States
Website: www.visionix.com
Email: regulatory@optovue.com
Phone: +1 800 729 1959
PRRC contact: Peter Sparacio(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 10 Nov 2027

TÜV Rheinland LGA Products GmbH 0197 1 certificate

HZ 1012635-1 Expiring Expires in 361 days

Quality management system EU MDR

Issued
8 Aug 2024

Expires
10 Nov 2027

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 3
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

6 initiated before 2017

2017
- 27 Jul 2017 Z-0008-2018 Class II Terminated FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Distribution: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN,…
  Full distribution text
  US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  Submission number: K121739
- 27 Jul 2017 Z-0009-2018 Class II Terminated FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Distribution: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN,…
  Full distribution text
  US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  Submission number: K130656
- 27 Jul 2017 Z-0010-2018 Class II Terminated FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Distribution: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN,…
  Full distribution text
  US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  Submission number: K133892
2016
- 16 Mar 2016 Z-1498-2016 Class II Terminated A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map. Distribution: PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming Submission numbers: K121739, K133892
2013
- 14 May 2013 Z-1441-2013 Class III Terminated Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. Distribution: Distributed Nationwide and in Canada. Submission number: K121739
2012
- 7 Sep 2012 Z-0024-2013 Class II Terminated Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description. Distribution: Worldwide Distribution -- USA (nationwide) and Internationally. Submission numbers: K091404, K101505
- 21 Feb 2012 Z-1340-2012 Not yet classified Terminated A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. Distribution: Nationwide Distribution -- CA and WA only Submission number: K111505
2010
- 20 Jul 2010 Z-1004-2011 Unclassified (pre-2012) Terminated Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. Distribution: Nationwide Submission number: K091404
- 8 Jan 2010 Z-1131-2010 Unclassified (pre-2012) Terminated Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database. Distribution: Nationwide and Worldwide

Frequently asked questions

How many devices does OPTOVUE, INC. have in the registry?

The registry currently lists 86 devices for OPTOVUE, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list OPTOVUE, INC.'s devices?

Among its 50 most recently registered devices, OPTOVUE, INC. has devices listed in EUDAMED (2 devices) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do OPTOVUE, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for OPTOVUE, INC.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for OPTOVUE, INC.?

FDA recall records list 9 recalls initiated by OPTOVUE, INC., the most recent initiated on 27 Jul 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for OPTOVUE, INC.?

EUDAMED lists 1 certificate for OPTOVUE, INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 8 Aug 2024.

What are the newest devices from OPTOVUE, INC. in the registry?

The most recently registered devices listed for OPTOVUE, INC. include Solix Essential, iVue iVue 100, RTVue XR Avanti 100 and RTVue XR Avanti 100-1.

Generated automatically from registry data and not verified by a human reviewer.