Neitz Halogen Binocular Indirect Ophthalmoscope IO-A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K942712 FDA 510(k)
- FDA Product Code
- HLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neitz Halogen Binocular Indirect Ophthalmoscope IO-A is an AC-powered ophthalmoscope designed for the examination of the ocular fundus. It utilizes an optical system that allows for the independent adjustment of spot size, illumination optical axis, and observation optical axis to facilitate observation of the peripheral ocular fundus.
This device is regulated as a Class 2 medical device and has received FDA 510(k) clearance. It is intended for use by clinical professionals to provide an adjustable observation angle for the operator during ophthalmic examinations.
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: Binocular Indirect Ophthalmoscopes - Neitz Instruments Co., Ltd., PDF Binocular Indirect Ophthalmoscope - 株式会社ナイツ, Neitz IO-α Indirect Ophthalmoscope Manual - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942712 | Class II | Active |
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Manufacturer
- Manufacturer
- Neitz Instruments Company, Ltd.
Sources (1)
- FDA 510(k) K942712 24 fields · synced Sep 24, 2026