PeriVision SA

PeriVision SA specializes in automated perimeter devices, which are primarily used for visual field testing. These devices measure retinal sensitivity and help identify abnormalities in peripheral vision. Examples include handheld lens holders and systems like the VisionOne VFT and VisionOne, all designed for ophthalmologic diagnostics.

PeriVision SA is based in Switzerland. Its devices are registered in the EUDAMED database, indicating compliance with European regulations, and are also listed in the FDA’s Unique Device Identifier (UDI) system, showing availability in the U.S. market.

PeriVision SA’s devices are classified as Class I and Class IIa medical devices under EU regulations. This classification is based on their intended use and risk level, with Class IIa indicating a moderate risk requiring additional scrutiny compared to Class I.

PeriVision SA’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices, and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking in both European and U.S. markets.

The classification of PeriVision SA’s devices as Class IIa (rather than Class I) is due to their intended use in diagnosing ophthalmologic conditions, which involves assessing retinal sensitivity and detecting vision abnormalities. While Class I devices pose minimal risk, Class IIa devices—like these perimeters—require more stringent controls because they play a critical role in diagnosing potential eye diseases, ensuring higher patient safety and regulatory oversight.