FITIPALDI DRIVING SUNGLASSES
Device Facts
| Record ID | K941415 |
|---|---|
| Device Name | FITIPALDI DRIVING SUNGLASSES |
| Applicant | L'Equipe Visual, Inc. |
| Product Code | HQY · Ophthalmic |
| Decision Date | May 9, 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.
