DORC INTRAOCULAR ELECTROMAGNET
Device Facts
| Record ID | K830336 |
|---|---|
| Device Name | DORC INTRAOCULAR ELECTROMAGNET |
| Applicant | Jedmed Instrument Co. |
| Product Code | HPO · Ophthalmic |
| Decision Date | Mar 9, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4440 |
| Device Class | Class 2 |
Regulatory Classification
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.
