Halogen Ophthalmo-Otoscope Set Bx A - 134
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950797 FDA 510(k)
- FDA Product Code
- HLJ 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 Halogen Ophthalmo-Otoscope Set BX A-134 is a battery-powered ophthalmic diagnostic device designed for otoscopy and ophthalmoscopy. It combines an otoscope with a rotating lens featuring 3x magnification and a fiberoptic light source, ensuring even illumination without color distortion for detailed examination of the ear and eye.
This set is supplied as a reusable diagnostic instrument, intended for clinical use in settings such as home visits or outpatient examinations. It includes a C-size battery handle, disposable ear tips for hygiene, and a halogen light source. The device holds FDA 510(k) clearance under regulation number 886.1570, classified as a Class II medical device under the Ophthalmic specialty category.
Frequently asked questions
Is this device designed for single-use or reusable in clinical settings, and what hygiene features does it include?
The Halogen Ophthalmo-Otoscope Set BX A-134 is a reusable diagnostic instrument, intended for repeated clinical use in settings like home visits or outpatient examinations. To maintain hygiene, it includes disposable ear tips, which can be replaced between patients to prevent cross-contamination. The reusable components are designed for thorough cleaning and sterilization between uses.
What magnification and light source does this ophthalmo-otoscope use, and how does it ensure clear visibility?
This device features a rotating lens with 3x magnification and a halogen light source, which provides even illumination without color distortion. The halogen bulb ensures bright, consistent lighting for detailed examination of both the ear and eye, reducing eye strain and improving diagnostic clarity.
How is the device powered, and what size battery does it use?
The Halogen Ophthalmo-Otoscope Set BX A-134 is battery-powered, utilizing a C-size battery handle. This design allows for portable use in clinical settings where access to electrical outlets may be limited, such as home visits or mobile examinations.
What regulatory pathway was followed for FDA clearance, and what classification does this device hold?
The device received FDA 510(k) clearance under regulation number 886.1570, classified as a Class II medical device within the Ophthalmic specialty category. The clearance was granted through a traditional 510(k) review, with a decision code indicating it was determined to be substantially equivalent to a predicate 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: BXα-134FO | Neitz Instruments Co., Ltd., Direct Ophthalmoscopes | Neitz Instruments Co., Ltd., Halogen Ophthalmo-otoscope Set Bx a - 134 - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950797 | Class II | Active |
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Manufacturer
- Manufacturer
- Neitz Instruments Company, Ltd.
Sources (1)
- FDA 510(k) K950797 24 fields · synced Sep 19, 2026