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) → HMR — Marker, Ocular

# HMR · Marker, Ocular

_Ophthalmic · 21 CFR 886.4570 · Class 1_

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

## Overview

- **Product Code:** HMR
- **Device Name:** Marker, Ocular
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K053475](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMR/K053475.md) | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | Refractec, Inc. | Mar 3, 2006 | SESE |
| [K925606](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMR/K925606.md) | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Chiron Vision Corp. | Aug 29, 1994 | SESE |
| [K872747](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMR/K872747.md) | LASER CENTERING DEVICE | Innomed Corp. | Sep 4, 1987 | SESE |
| [K863663](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMR/K863663.md) | OPHTHALMIC SURGICAL OCULAR MARKERS | Myocure, Inc. | Oct 20, 1986 | SESE |
| [K861535](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMR/K861535.md) | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | CooperVision, Inc. | May 14, 1986 | SESE |

## Top Applicants

- Refractec, Inc. — 1 clearance
- Myocure, Inc. — 1 clearance
- Innomed Corp. — 1 clearance
- CooperVision, Inc. — 1 clearance
- Chiron Vision Corp. — 1 clearance

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

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