Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4440](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4440) → HPO — Magnet, Ac-Powered

# HPO · Magnet, Ac-Powered

_Ophthalmic · 21 CFR 886.4440 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO

## Overview

- **Product Code:** HPO
- **Device Name:** Magnet, Ac-Powered
- **Regulation:** [21 CFR 886.4440](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4440)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Special Controls

*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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854870](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO/K854870.md) | INTRAOCULAR ELECTROMAGNET | Mira, Inc. | Feb 19, 1986 | SESE |
| [K832950](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO/K832950.md) | SCIENTRONICS 10K EYE MAGNET | Scientific Manufacturer | Oct 19, 1983 | SESE |
| [K830336](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO/K830336.md) | DORC INTRAOCULAR ELECTROMAGNET | Jedmed Instrument Co. | Mar 9, 1983 | SESE |

## Top Applicants

- Jedmed Instrument Co. — 1 clearance
- Mira, Inc. — 1 clearance
- Scientific Manufacturer — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO)

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