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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPO | Magnet, Ac-Powered | 2 | 3 |
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