IVANTIS, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3016075957

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016075957
FEI Number
3007683266
Entity Name
IVANTIS, INC.
City/State/Country
Irvine, CA, US
Establishment Address
201 Technology Dr., Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Alcon Laboratories, Inc. (Owner Number: 1610287)
Owner / Operator Contact Address
6201 South Freeway, Fort Worth, TX 76134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OGO Intraocular Pressure Lowering Implant Unknown Class 3 N/A 2017-12-18
OGO Intraocular Pressure Lowering Implant Unknown Class 3 N/A 2022-01-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alcon Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016075957. Last updated year: 2026. Please use registration number 3016075957 when referencing this establishment in official correspondence.
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