OPTICAL FRAMES AND/OR SUNGLASSES
Device Facts
| Record ID | K935729 |
|---|---|
| Device Name | OPTICAL FRAMES AND/OR SUNGLASSES |
| Applicant | Ivo Eyewear, Inc. |
| Product Code | HQZ · Ophthalmic |
| Decision Date | Feb 16, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5842 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
