Identifiers
- 510(k) Number
- K113066 FDA 510(k)
- FDA Product Code
- HKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Corvis ST is an Ac-Powered Non-Contact Tonometer designed to measure corneal biomechanics. It employs a high-speed Scheimpflug camera to capture the dynamic deformation response of the cornea in response to an air pulse, enabling assessment of corneal stiffness and biomechanical properties.
This device is intended for use in ophthalmic settings and is supplied as a reusable medical instrument. Authorized under FDA 510K and MDR, it operates within Device Class II and is regulated under 886.1930. The Corvis ST requires AC power and is not intended for MRI environments. Storage and handling follow standard clinical device protocols.
Frequently asked questions
What clinical applications does the Corvis ST support in ophthalmology, and how does it differ from traditional tonometry?
The Corvis ST measures corneal biomechanics by capturing dynamic corneal deformation in response to an air pulse, providing insights into corneal stiffness and biomechanical properties. Unlike traditional tonometry, which primarily measures intraocular pressure, the Corvis ST offers a non-contact assessment of corneal health and structural integrity, useful for evaluating conditions like keratoconus, corneal ectasia, or post-surgical changes. Its high-speed Scheimpflug camera enables detailed biomechanical analysis beyond pressure measurement alone.
Is the Corvis ST designed for single-use or reusable clinical settings, and what maintenance considerations apply?
The Corvis ST is explicitly supplied as a reusable medical instrument for ophthalmic use. As a reusable device, it requires adherence to standard clinical cleaning, disinfection, and sterilization protocols to ensure patient safety and device integrity. The manufacturer’s instructions (not provided here) should be followed for proper maintenance, including air filtration and periodic servicing, as it operates with AC power and contains mechanical components.
What power requirements and environmental limitations should clinicians be aware of when using the Corvis ST?
The Corvis ST is AC-powered and not intended for use in MRI environments due to its electronic and mechanical components. Clinicians should ensure it is plugged into a stable power source and placed in a dry, temperature-controlled environment to avoid operational disruptions. The device’s design prioritizes non-contact use, eliminating the need for direct patient contact during measurements.
How does the regulatory pathway for the Corvis ST affect its availability or use in clinical settings?
The Corvis ST is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, confirming its compliance with stringent safety and performance standards in the U.S. and EU markets. This regulatory clearance ensures its use is supported by validated clinical evidence and manufacturing controls, though clinicians should verify local compliance requirements (e.g., facility protocols or licensing) before integration into practice.
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: Corvis® ST - Deformation response, Tonometry, Pachymetry - OCULUS Germany, Non-Contact-Tonometer OCULUS Corvis® ST - OCULUS Optikgeräte GmbH, Biomechanik - OCULUS Corvis® ST, Oculus Corvis ST, OCULUS Corvis® ST | OCULUS Optikgeräte GmbH | Produkt - EYEFOX
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 | K113066 | Class II | Active |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- FDA Applicant
- Oculus Optikgerate GmbH
Sources (2)
- FDA 510(k) K113066 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026