21 CFR 886.5840 — Spectacle, Magnifying
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5840
Identification
Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HOI | Spectacle, Magnifying | 1 | 11 |
