Regulation Text
(a) Identification. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.