SUNGLASSES
Device Facts
| Record ID | K910329 |
|---|---|
| Device Name | SUNGLASSES |
| Applicant | Cutler & Gross Sloan Optical , Ltd. |
| Product Code | HOI · Ophthalmic |
| Decision Date | Mar 12, 1991 |
| 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.
