Smart Vision Labs has received CE mark approval for SVOne in Europe, according to a press release.
SVOne, an FDA class 1 exempt device, is a hand-held Shack-Hartmann wavefront aberrometer that measures objective refractive error in children and adults.
“The CE mark is a significant step forward in the commercialization of SVOne in Europe,” Marc Albanese, chief operating officer and co-founder of Smart Vision Labs, said in the release. “With the CE mark, our company’s mission to make vision care globally accessible will be even more attainable.”
In addition, the company recently released SVOne Enterprise, which features self-guided refraction technology, and SVOne Pro, which offers a sphere range from –14 D to +14 D and a cylinder range from –7 D to +7 D.