Sensimed Triggerfish
FDA 510(k)Class II (US FDA 510(k))
by Sensimed AG
Identifiers
- 510(k) Number
- DEN140017 FDA 510(k)
- FDA Product Code
- PLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1925 FDA 510(k)
- Regulation Number
- 886.1925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Sensimed Triggerfish is an ocular pattern recorder, a device used for continuous ocular monitoring. It includes a smart contact lens that captures spontaneous changes in the eye, providing valuable information to guide glaucoma treatment. The device is designed to detect intraocular pressure-related changes in an eye over a 24-hour period.
The Sensimed Triggerfish is supplied as a single-use device and is intended for use in ophthalmic applications. It has received FDA 510K authorization and is classified as a class 2 device. The device is available in a specific configuration, as indicated by its product code PLZ, and is registered with the FDA under the regulation number 886.1925.
Frequently asked questions
What is the Sensimed Triggerfish used for?
The Sensimed Triggerfish is used for continuous ocular monitoring, providing valuable information to guide glaucoma treatment by detecting intraocular pressure-related changes in an eye over a 24-hour period.
Is the Sensimed Triggerfish a single-use or reusable device?
The Sensimed Triggerfish is supplied as a single-use device, intended for use in ophthalmic applications.
What type of authorization has the Sensimed Triggerfish received?
The Sensimed Triggerfish has received FDA 510K authorization and is classified as a class 2 device.
How is the Sensimed Triggerfish configured?
The Sensimed Triggerfish is available in a specific configuration, as indicated by its product code PLZ.
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: Sensimed Triggerfish - Sensimed S.A., Sensimed S.A. - Sensimed Website, Full article: The Sensimed Triggerfish contact lens sensor: efficacy ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN140017 | Class II | Active |
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Manufacturer
- Manufacturer
- Sensimed AG
Sources (1)
- FDA 510(k) DEN140017 24 fields · synced Sep 25, 2026