Optical Coherence Tomography SOLIX
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Solix EUDAMED
- Device Name
- Solix EUDAMED
- Model / Reference
- Solix EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858848006803 EUDAMED
- Basic UDI-DI
- 08588480068037K EUDAMED
- Direct Marketing DI
- 00858848006803 EUDAMED
- 510(k) Number
- K222166 FDA 510(k)
- FDA Product Code
- OBO FDA 510(k)
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The SOLIX is an Optical Coherence Tomography (OCT) device, classified as a Class II medical device under FDA regulations. It provides high-resolution, cross-sectional imaging of the retina, enabling detailed visualization of retinal layers, fluid accumulation, and structural abnormalities for diagnostic and monitoring purposes in ophthalmic care.
This device is supplied as a standalone imaging system intended for use in clinical settings such as ophthalmology offices, hospitals, and diagnostic centers. It operates as a reusable instrument with no indication of sterility requirements in the provided data. The SOLIX adheres to FDA 510K clearance and EU MDR authorizations, with a product code classification of OBO (Ophthalmic, Diagnostic, Other). Multiple registration numbers and FEI numbers are associated with its various configurations, reflecting its application across multiple ophthalmic diagnostic scenarios.
Frequently asked questions
What clinical scenarios is the SOLIX Optical Coherence Tomography (OCT) device designed to support in ophthalmology?
The SOLIX OCT device is specifically designed for high-resolution imaging of the retina, enabling detailed visualization of retinal layers, fluid accumulation, and structural abnormalities. This makes it particularly useful for diagnosing and monitoring conditions such as diabetic retinopathy, macular degeneration, glaucoma, and other retinal pathologies in clinical settings like ophthalmology offices, hospitals, and diagnostic centers.
Is the SOLIX device intended for single-use or reusable applications, and are there any sterility requirements mentioned?
The SOLIX is described as a reusable instrument, meaning it is designed for repeated use in clinical environments. The provided data does not specify any sterility requirements, so proper cleaning and maintenance protocols would need to be followed as per manufacturer guidelines to ensure safe and effective reuse.
What regulatory pathways has the SOLIX OCT device undergone, and how does this impact its use in different regions?
The SOLIX has undergone FDA 510(k) clearance and EU MDR authorization, confirming its compliance with U.S. and European regulatory standards. This dual authorization allows the device to be legally marketed and used in both the United States and the European Economic Area, adhering to their respective medical device regulations.
How many different configurations or models of the SOLIX OCT device are available, and how can I identify them?
The SOLIX device comes in multiple configurations, each associated with distinct FEI numbers (e.g., 3004441848, 3002807782, etc.) and registration numbers (e.g., 9611269, 3005950902, etc.). These identifiers help distinguish between different models or software versions, ensuring compatibility with specific clinical or diagnostic needs. The manufacturer’s documentation or support team can clarify which configuration aligns with your requirements.
What type of facility or setting is the SOLIX OCT device intended for, and does it require any special installation or maintenance?
The SOLIX is supplied as a standalone imaging system intended for clinical settings such as ophthalmology offices, hospitals, and diagnostic centers. While the data does not specify installation requirements, its classification as a reusable Class II device implies it may require routine maintenance, calibration, and adherence to manufacturer-recommended procedures to ensure accurate and reliable performance over time.
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 | K222166 | Class II | Active |
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Manufacturer
- Manufacturer
- Optovue, Inc.
Sources (2)
- FDA 510(k) K222166 24 fields · synced Sep 18, 2026
- EUDAMED fc413bf9-51de-4fdd-bb0d-60f25b6e05fc 61 fields · synced Jul 27, 2026