Article

3-D camera 501(k)

The FDA has granted 501(k) approval to Kowa Optimed Inc. for the marketing of its non-mydriatic 3-D retinal camera, the nonmyd WX3D, for simultaneous stereoscopic retinal photography.

Torrance, CA-The FDA has granted 501(k) approval to Kowa Optimed Inc. for the marketing of its non-mydriatic 3-D retinal camera, the nonmyd WX3D, for simultaneous stereoscopic retinal photography.

This new retinal camera brings state-of-the-art simultaneous stereoscopic photography to Kowa’s integrated normal and small pupil settings. The added capability of 3-D photography of the optics disc will enable practitioners to diagnose glaucoma properly.

Kowa is ready for immediate marketing of its nonmydriatic 3-D retinal camera and has scheduled formal launches at both Vision Expo East in New York, March 16 to 20, and at the annual meeting of the American Society of Cataract and Refractive Surgery in San Diego, March 25 to 29.

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