Identifiers
- 510(k) Number
- K043213 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Kowa VX-10 is an AC-powered ophthalmic camera designed to capture fundus images. It functions as a two-in-one device capable of performing both mydriatic and non-mydriatic imaging.
This device is cleared for use through the FDA 510(k) regulatory pathway. It is classified as a Class 2 ophthalmic device and is intended for clinical ophthalmic applications.
Frequently asked questions
What is the primary function of the Kowa VX-10?
The Kowa VX-10 is an AC-powered ophthalmic camera intended for clinical ophthalmic applications to capture images of the fundus.
Does the Kowa VX-10 support different imaging modes?
Yes, the device is designed as a two-in-one system, which allows clinicians to perform both mydriatic and non-mydriatic fundus imaging.
What is the regulatory status of this ophthalmic camera?
The Kowa VX-10 is cleared for use through the FDA 510(k) regulatory pathway and is classified as a Class 2 ophthalmic device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Two-In-One Non-Mydriatic and Mydriatic Fundus Cameras. - kowa-usa.com, K043213 FDA 510 (k) - KOWA VX-10 | Kowa Co. , Ltd., KOWA VX-10 by KOWA CO. LTD. | FDA 510 (k) Summary, PDF VX-10 / VX-10 i, Two-In-One Non-Mydriatic The new VX-10 i ... - Pulchart
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043213 | Class II | Active |
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Manufacturer
- Manufacturer
- Kowa Co. , Ltd.
Sources (1)
- FDA 510(k) K043213 24 fields · synced Sep 24, 2026