Smart Vision Labs announced that SVOne, a handheld Shack-Hartmann wavefront aberrometer, has received CE Mark approval. SVOne Pro is an upgraded version of the company’s core handheld technology with an increased range of power that covers the vision needs of 99% of the population, according a company news release.
“The CE mark is a significant step forward in the commercialization of SVOne in Europe,” COO and Co-founder Marc Albanese said in a company news release. “We’ve had a lot of interest from this market. With the CE Mark, our company’s mission to make vision care globally accessible will be even more attainable.”
SVOne, an FDA Class 1 exempt device, weighs less than 1 pound. Data from the device can be stored on a HIPAA-compliant cloud platform and extends the versatility of SVOne for use in telemedicine medicine programs. The sphere range of the SVOne is -14.00 to +14.00 D, and the cylinder range is -7.00 D to +7.00 D.
Smart Vision also recently released the SVOne Enterprise, which features self-guided refraction technology, combining the power of mobile computation, precision optics, and connectivity.