HPN · Magnet, Permanent
Ophthalmic · 21 CFR 886.4445 · Class 1
Overview
| Product Code | HPN |
|---|---|
| Device Name | Magnet, Permanent |
| Regulation | 21 CFR 886.4445 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.
Classification Rationale
Class I (general 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K905237 | EYE SEE INSTRUMENT | King Tool, Inc. | Feb 14, 1991 | SESE |
| K896473 | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR | Emory University School of Medicine | Feb 9, 1990 | SESE |
| K880855 | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | Richard James, Inc. | Apr 1, 1988 | SESE |
| K860960 | RARE EARTH INTRA-OCULAR MAGNET | Ameritek, Inc. | Mar 31, 1986 | SESE |
| K831702 | RARE-EARTH INTRA-OCULAR MAGNET | Miami Eye Technology, Inc. | Jun 30, 1983 | SESE |
Top Applicants
- Richard James, Inc. — 1 clearance
- Miami Eye Technology, Inc. — 1 clearance
- King Tool, Inc. — 1 clearance
- Emory University School of Medicine — 1 clearance
- Ameritek, Inc. — 1 clearance
