FTZ · Locator, Magnetic
Ophthalmic · 21 CFR 886.4445 · Class 1
Overview
| Product Code | FTZ |
|---|---|
| Device Name | Locator, Magnetic |
| 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 (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833229 | SUN BED BY VERRE ET QUARTZ UVA-FRANCE | H & M Douglas Enterprises, Inc. | Jan 27, 1984 | SESE |
| K830468 | MODEL 200 | Western Laboratories Corp. | Apr 12, 1983 | SESE |
Top Applicants
- Western Laboratories Corp. — 1 clearance
- H & M Douglas Enterprises, Inc. — 1 clearance
