DIOPSYS INC.

FDA Device Registration & Listing · Middletown, PA, US · Registration 3004174467

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
3004174467
FEI Number
3004174467
Entity Name
DIOPSYS INC.
City/State/Country
Middletown, PA, US
Establishment Address
1000 Kreider Drive, STE 700, Middletown, PA 17057, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OpZira, Inc. (Owner Number: 10093974)
Owner / Operator Contact Address
1000 Kreider Drive, STE 700, Middletown, PA 17057, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101763
PMA Number
N/A

All Registered Proprietary Names

NOVA Vision Testing System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2025-08-27

Official Correspondent

Lori Holder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016500342 AdaptDx, Inc Middletown, PA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004174467. Last updated year: 2026. Please use registration number 3004174467 when referencing this establishment in official correspondence.
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