Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4400](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4400) → HPM — Locator, Metal, Electronic

# HPM · Locator, Metal, Electronic

_Ophthalmic · 21 CFR 886.4400 · Class 2_

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

## Overview

- **Product Code:** HPM
- **Device Name:** Locator, Metal, Electronic
- **Regulation:** [21 CFR 886.4400](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4400)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K003305](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K003305.md) | PEDIATRIC INGESTASCAN | Adams Electronics, Inc. | Dec 22, 2000 | SESE |
| [K953277](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K953277.md) | SHADOW MEDAL LOCATOR | Fatswith Intl., Inc. | Apr 1, 1996 | SESE |
| [K911886](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K911886.md) | PMT METAL LOCATOR, MODEL 3630-1 | Pmt Corp. | Aug 12, 1991 | SESE |
| [K781892](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K781892.md) | LOCATOR, FOREIGN BODY | Keeler Optical Products , Ltd. | Dec 4, 1978 | SESE |

## Top Applicants

- Adams Electronics, Inc. — 1 clearance
- Fatswith Intl., Inc. — 1 clearance
- Keeler Optical Products , Ltd. — 1 clearance
- Pmt Corp. — 1 clearance

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

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