Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) → QDY — Vitrectomy Kit

# QDY · Vitrectomy Kit

_Ophthalmic · 21 CFR 886.4150 · Class 2_

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

## Overview

- **Product Code:** QDY
- **Device Name:** Vitrectomy Kit
- **Regulation:** [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

## Classification Rationale

Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, 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, when it is phacofragmentation unit replacement tubing, 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/QDY](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/QDY)

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