21 CFR 886.1415 — Frame, Trial, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1415
Identification
An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.
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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPA | Frame, Trial, Ophthalmic | 1 | 5 |
