Section 886.5910 - Image intensification vision aid(a)Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9 . The 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.52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814 , July 25, 2001