21 CFR 886.1420 — Gauge, Lens, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1420
Identification
An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle 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 |
|---|---|---|---|---|
| HLN | Gauge, Lens, Ophthalmic | 1 | 2 |
