21 CFR 886.5100 — Unit, Beta, Radiation, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5100
Identification
An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HRL | Unit, Beta, Radiation, Ophthalmic | 2 | 0 | 3rd Party |
