(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 Sec. 886.9. [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001]