MAGNIFYING SPECTACLES W/PLASTIC LENSES
Device Facts
| Record ID | K844716 |
|---|---|
| Device Name | MAGNIFYING SPECTACLES W/PLASTIC LENSES |
| Applicant | Gazelle Corp. |
| Product Code | HOI · Ophthalmic |
| Decision Date | Jan 3, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5840 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
