SPECTACLE, FRAME AND SUNGLASSES
Device Facts
| Record ID | K881278 |
|---|---|
| Device Name | SPECTACLE, FRAME AND SUNGLASSES |
| Applicant | Nouvelle Ligne Paris |
| Product Code | HQY · Ophthalmic |
| Decision Date | May 25, 1988 |
| 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.
