21 CFR 886.1405 — Set, Lens, Trial, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1405
Identification
An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
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 |
|---|---|---|---|---|
| HPC | Set, Lens, Trial, Ophthalmic | 1 | 13 |
