SUNGLASSES
Device Facts
| Record ID | K940969 |
|---|---|
| Device Name | SUNGLASSES |
| Applicant | Tzong Rong Sunglasses Mfg. Co., Ltd. |
| Product Code | HQY · Ophthalmic |
| Decision Date | Aug 16, 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.
