Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5100](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5100) → HRL — Unit, Beta, Radiation, Ophthalmic

# HRL · Unit, Beta, Radiation, Ophthalmic

_Ophthalmic · 21 CFR 886.5100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRL

## Overview

- **Product Code:** HRL
- **Device Name:** Unit, Beta, Radiation, Ophthalmic
- **Regulation:** [21 CFR 886.5100](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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._

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRL](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HRL)

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