21 CFR § 886.4440
AC-powered magnet
June 25, 2020
(a) Identification. An AC-powered magnet is an AC-powered device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
(b) Classification. Class II (special 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.
[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]