Regulation Text
(a) Identification. An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).
(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.