← Product Code [HPM](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM) · K781892

# LOCATOR, FOREIGN BODY (K781892)

_Keeler Optical Products , Ltd. · HPM · Dec 4, 1978 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K781892

## Device Facts

- **Applicant:** Keeler Optical Products , Ltd.
- **Product Code:** [HPM](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM.md)
- **Decision Date:** Dec 4, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4400
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

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

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K781892](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPM/K781892)

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