HRL · Unit, Beta, Radiation, Ophthalmic
Ophthalmic · 21 CFR 886.5100 · Class 2
Overview
| Product Code | HRL |
|---|---|
| Device Name | Unit, Beta, Radiation, Ophthalmic |
| Regulation | 21 CFR 886.5100 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
