HPO · Magnet, Ac-Powered
Ophthalmic · 21 CFR 886.4440 · Class 2
Overview
| Product Code | HPO |
|---|---|
| Device Name | Magnet, Ac-Powered |
| Regulation | 21 CFR 886.4440 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854870 | INTRAOCULAR ELECTROMAGNET | Mira, Inc. | Feb 19, 1986 | SESE |
| K832950 | SCIENTRONICS 10K EYE MAGNET | Scientific Manufacturer | Oct 19, 1983 | SESE |
| K830336 | DORC INTRAOCULAR ELECTROMAGNET | Jedmed Instrument Co. | Mar 9, 1983 | SESE |
Top Applicants
- Scientific Manufacturer — 1 clearance
- Mira, Inc. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
