Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021892531

FEI Number

3021892531

Entity Name

ACUCELA DBA KUBOTA VISION

City/State/Country

Seattle, WA, US

Establishment Address

107 Spring St, Seattle, WA 98104, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Acucela Inc. DBA Kubota Vision Inc. (Owner Number: 10085366)

Owner / Operator Contact Address

107 Spring Street, Seattle, WA 98104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kubota Glass

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOT	Aid, Vision Image Intensification	Ophthalmic	Class 1	886.5910	2022-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Acucela Inc. DBA Kubota Vision 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 3021892531. Last updated year: 2026. Please use registration number 3021892531 when referencing this establishment in official correspondence.