Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4570](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4570) → HRP — Pen, Marking, Surgical

# HRP · Pen, Marking, Surgical

_Ophthalmic · 21 CFR 886.4570 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRP

## Overview

- **Product Code:** HRP
- **Device Name:** Pen, Marking, Surgical
- **Regulation:** [21 CFR 886.4570](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4570)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRP](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRP)

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