Tomey Cornea/Anterior Segment OCT CASIA2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213265 FDA 510(k)
- FDA Product Code
- OBO 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 Tomey Cornea/Anterior Segment OCT CASIA2 is an optical coherence tomography device that analyzes both the anterior and posterior surfaces of the cornea using high-resolution images. It is designed to reduce the impact of corneal irregularities or opacities compared to conventional methods. The device produces high-resolution cross-sectional images with a 16mm diameter, providing detailed visualization of corneal structure and layers.
The CASIA2 is supplied as a medical device and is authorized under FDA 510K clearance with product code OBO. It is intended for use in ophthalmic settings and requires proper training to ensure safe operation. The device should be stored according to manufacturer instructions and maintained according to the provided manual to ensure optimal performance and safety.
Frequently asked questions
What is the Tomey CASIA2 OCT used for?
The Tomey CASIA2 OCT is an optical coherence tomography device designed to analyze both the anterior and posterior surfaces of the cornea using high-resolution images, providing detailed visualization of corneal structure and layers.
How is the CASIA2 OCT supplied and what are its storage requirements?
The CASIA2 OCT is supplied as a medical device and should be stored according to manufacturer instructions. It requires proper training to ensure safe operation and should be maintained according to the provided manual for optimal performance and safety.
What is the imaging capability of the CASIA2 OCT?
The CASIA2 OCT produces high-resolution cross-sectional images with a 16mm diameter, designed to reduce the impact of corneal irregularities or opacities compared to conventional methods, providing detailed visualization of corneal structure and layers.
What is the regulatory status of the Tomey CASIA2 OCT?
The Tomey CASIA2 OCT is authorized under FDA 510K clearance with product code OBO, having received a decision code of SESE (Substantially Equivalent) on 2022-04-27, with the application received on 2021-09-30.
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: CASIA2: OCT - TOMEY GmbH, PDF Cornea/Anterior Segment OCT CASIA2 - tomeyusa.com, Tomey Corneal and Anterior Segment OCT CASIA2 - US Ophthalmic, TOMEY Corneal and Anterior Segment OCT CASIA2, PDF tomey-CASIA2-manual - Ophthalmic Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213265 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomey Corporation
Sources (1)
- FDA 510(k) K213265 24 fields · synced Sep 25, 2026