SYSTEMS OF SIGHT LOW VISION EYEWARE
Device Facts
| Record ID | K854854 |
|---|---|
| Device Name | SYSTEMS OF SIGHT LOW VISION EYEWARE |
| Applicant | Int'L Eye Care, Inc. |
| Product Code | HOI · Ophthalmic |
| Decision Date | Feb 4, 1986 |
| 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.
