← Product Code [HPO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO) · K830336

# DORC INTRAOCULAR ELECTROMAGNET (K830336)

_Jedmed Instrument Co. · HPO · Mar 9, 1983 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO/K830336

## Device Facts

- **Applicant:** Jedmed Instrument Co.
- **Product Code:** [HPO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO.md)
- **Decision Date:** Mar 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4440
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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/HPO/K830336](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPO/K830336)

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