Eidon Fa, Eidon, Eidon Af, Eidon Uwfl
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211328 FDA 510(k)
- FDA Product Code
- MYC 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 Eidon FA, Eidon, Eidon AF, and Eidon UWFL are Scanning Laser Ophthalmoscopes, designed for retinal imaging and diagnostic evaluation of the eye. These devices utilize laser scanning technology to capture high-resolution images of the retina, enabling clinicians to assess retinal health, detect abnormalities, and monitor conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration (AMD).
These devices are intended for use in ophthalmic clinical settings and are supplied as reusable medical instruments. They are classified under Device Class II and comply with FDA 510(k) clearance, MDD, and MDR regulations. The Eidon series includes multiple models, each tailored for specific diagnostic applications, and must be operated by trained professionals in accordance with manufacturer instructions.
Frequently asked questions
What types of retinal conditions can the Eidon series help diagnose or monitor, and how does the laser scanning technology assist in this process?
The Eidon FA, Eidon, Eidon AF, and Eidon UWFL devices are designed to diagnose and monitor retinal conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration (AMD). The laser scanning technology captures high-resolution images of the retina, allowing clinicians to detect abnormalities like microaneurysms, hemorrhages, or structural changes in the retinal layers that may indicate these conditions. This precise imaging helps in early detection and ongoing monitoring of disease progression.
Are these devices single-use or reusable, and what maintenance or cleaning procedures should be followed?
The Eidon series is supplied as reusable medical instruments, meaning they are intended for repeated use in clinical settings. Since they are reusable, proper cleaning, disinfection, and maintenance procedures must be followed as outlined in the manufacturer’s instructions to ensure sterility and functionality between uses. This includes adherence to protocols for high-level disinfection or sterilization, depending on the specific use case and local regulatory requirements.
What models are included in the Eidon series, and how do they differ in their intended diagnostic applications?
The Eidon series includes four models: Eidon FA, Eidon, Eidon AF, and Eidon UWFL. While all are scanning laser ophthalmoscopes for retinal imaging, each model may be tailored for specific diagnostic needs—such as fundus autofluorescence (FA), angiography (AF), or ultra-wide field imaging (UWFL)—to provide specialized views or assessments of retinal health. The exact differences in functionality are detailed in the manufacturer’s instructions, which guide clinicians on selecting the appropriate model for their diagnostic requirements.
How should these devices be stored when not in use, and are there any specific environmental conditions that must be maintained?
The Eidon series should be stored in a clean, dry environment, protected from dust, moisture, and direct sunlight, as per the manufacturer’s guidelines. Proper storage ensures the device remains functional and maintains its performance for accurate retinal imaging. Environmental conditions like temperature and humidity may also be specified in the user manual to prevent damage to the optical or electronic components.
What regulatory pathways have these devices undergone, and how does this affect their use in clinical settings?
The Eidon series has undergone FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These pathways confirm that the devices meet regulatory standards for safety and effectiveness in ophthalmic settings. Clinicians should refer to the manufacturer’s documentation for specific instructions on use, as these devices must be operated by trained professionals following established protocols to ensure proper diagnostic outcomes.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211328 | Class II | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
Sources (2)
- FDA 510(k) K211328 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026