21 CFR 886.5842 — Frame, Spectacle
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5842
Identification
A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.
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 the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQZ | Frame, Spectacle | 1 | 198 |
