DBA FOCAL CHANGE FRAMES
Device Facts
| Record ID | K923415 |
|---|---|
| Device Name | DBA FOCAL CHANGE FRAMES |
| Applicant | Focal Change |
| Product Code | HQZ · Ophthalmic |
| Decision Date | Oct 13, 1992 |
| 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.
