21 CFR § 886.1435 Ophthalmic Devices

§ 886.1435 Maxwell spot.

Current through Sep 8, 2026 · Read all of Part 886

(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.

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

← § 886.1430 Ophthalmic contact lens radius measuring device.§ 886.1450 Corneal radius measuring device. →