21 CFR 886.4440 — Magnet, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4440

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HPOMagnet, Ac-Powered23

Special Controls

HPO — Magnet, Ac-Powered

*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.

eCFR

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