21 CFR 886.1660 — Prism, Gonioscopic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1660
Identification
A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.
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 |
|---|---|---|---|---|
| HKS | Prism, Gonioscopic | 1 | 10 |
