StacksVerified U.S. regulatory reference

21 CFR §886.1435

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  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.