Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4790](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4790) → OJK — Eye Tray

# OJK · Eye Tray

_Ophthalmic · 21 CFR 886.4790 · Class 2_

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

## Overview

- **Product Code:** OJK
- **Device Name:** Eye Tray
- **Regulation:** [21 CFR 886.4790](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4790)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

## Classification Rationale

Class II (special 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.

## Special Controls

*Classification.* Class II (special 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/OJK](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OJK)

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