21 CFR 886.1430 — Device, Measuring, Lens Radius, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1430
Identification
An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.
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 |
|---|---|---|---|---|
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 1 | 3 |