Regulation Text
(a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.
(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 management system regulation in part 820 of this chapter , except for requirements concerning records and complaint files under § 820.35 of this chapter .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.