(a) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
(b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.