VISEON, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3014388471

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
3014388471
FEI Number
3014388471
Entity Name
VISEON, INC.
City/State/Country
Irvine, CA, US
Establishment Address
13700 Alton Parkway, Suite 167, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Viseon, Inc. (Owner Number: 10057389)
Owner / Operator Contact Address
13700 Alton Parkway, Suite 167, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181885
PMA Number
N/A

All Registered Proprietary Names

Hubble EXCITE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2025-03-13
FSQ Light, Surgical, Instrument General, Plastic Surgery Class 2 878.4580 2024-02-05
HRX Arthroscope Orthopedic Class 2 888.1100 2019-08-05
HRX Arthroscope Orthopedic Class 2 888.1100 2018-10-12

Official Correspondent

Cora Sim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014388471. Last updated year: 2026. Please use registration number 3014388471 when referencing this establishment in official correspondence.
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