21 CFR §886.1655

1. (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.
2. (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.