21 CFR 886.5850 — Sunglasses (Non-Prescription Including Photosensitive)
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5850
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 1 | 646 |
