Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015217553

FEI Number

3015217553

Entity Name

AOMI PRECISION CO. LTD.

City/State/Country

NIIGATA, JP

Establishment Address

787, SHIMOMAGARIDORI, MINAMI-KU, NIIGATA 950-1301, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AOMI PRECISION CO. LTD. (Owner Number: 10088131)

Owner / Operator Contact Address

787, SHIMOMAGARIDORI, MINAMI-KU, NIIGATA, JP-15 950-1301, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iStent inject Trabecular Micro-Bypass System, Model G2-M-IS; iStent inject W Trabecular Micro-Bypass System, Model G2-W

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	2023-05-30

Official Correspondent

No official correspondent registered.

US Agent Details

Tora Hoppe Business: Advanced Micro Precision, LLC. Email: thoppe@am-precision.com Phone: (562) 2019534

Related Public Records

Same Entity

AOMI PRECISION CO. LTD.

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 3015217553. Last updated year: 2026. Please use registration number 3015217553 when referencing this establishment in official correspondence.