OPTICAL FRAMES AND SUNGLASSES
Device Facts
| Record ID | K944526 |
|---|---|
| Device Name | OPTICAL FRAMES AND SUNGLASSES |
| Applicant | Aprilia Eyewear S.P.A. |
| Product Code | HQY · Ophthalmic |
| Decision Date | Nov 15, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
