Confoscan 2 Confocal Microscope
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012416 FDA 510(k)
- FDA Product Code
- HJO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Confoscan 2 Confocal Microscope is a slit-lamp biomicroscope designed for high-resolution imaging of the anterior segment of the eye. It employs confocal microscopy to provide detailed visualization of ocular structures, including the cornea, iris, and trabecular meshwork, aiding in diagnostic and research applications within ophthalmology.
This device is intended for use in clinical and research settings, supplied as a reusable medical instrument. It operates on AC power and is classified under FDA regulation 886.1850 as a Class II device, with FDA 510K and MDR authorizations. The microscope is not labeled as single-use and requires proper maintenance and calibration to ensure accurate imaging performance.
Frequently asked questions
What types of ocular structures can the Confoscan 2 Confocal Microscope visualize, and how does it achieve this level of detail?
The Confoscan 2 Confocal Microscope specializes in high-resolution imaging of the anterior segment of the eye, including the cornea, iris, and trabecular meshwork. It achieves this detail through confocal microscopy, a technique that enhances clarity by focusing on a single plane of the tissue while eliminating out-of-focus light, resulting in sharp, precise images for diagnostic and research purposes.
Is the Confoscan 2 Confocal Microscope designed for single-use or reusable applications, and what maintenance is required?
The Confoscan 2 is explicitly labeled as a reusable medical instrument, not single-use. To ensure accurate imaging performance, it requires proper maintenance and calibration, as outlined in the manufacturer’s guidelines, to sustain its functionality over repeated clinical or research use.
What power source does the Confoscan 2 Confocal Microscope use, and is it suitable for both clinical and research environments?
The Confoscan 2 operates on AC power, making it suitable for both clinical and research settings where stable electrical infrastructure is available. Its design aligns with ophthalmic diagnostic needs, supporting detailed imaging in controlled environments like hospitals, clinics, or research labs.
How is the regulatory status of the Confoscan 2 Confocal Microscope defined, and which governing bodies have authorized its use?
The Confoscan 2 holds FDA 510K clearance and MDR authorization, confirming its compliance with U.S. and European regulatory standards. It is classified as a Class II device under FDA regulation 886.1850, with a traditional clearance pathway through the Ophthalmic (OP) advisory committee, ensuring its safety and effectiveness for intended use in ophthalmology.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K012416 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek Technologies Srl
Sources (2)
- FDA 510(k) K012416 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026