Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) → QLY — Ophthalmic Syringe

# QLY · Ophthalmic Syringe

_General Hospital · 21 CFR 880.5860 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY

## Overview

- **Product Code:** QLY
- **Device Name:** Ophthalmic Syringe
- **Regulation:** [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251849](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K251849.md) | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | Nov 21, 2025 | SESE |
| [K243322](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K243322.md) | Altaviz Intravitreal Syringe | Altaviz, LLC | May 9, 2025 | SESE |
| [K243027](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K243027.md) | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | Apr 8, 2025 | SESE |
| [K243936](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K243936.md) | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | Apr 3, 2025 | SESE |
| [K243149](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K243149.md) | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | Dec 20, 2024 | SESE |
| [K230372](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K230372.md) | VitreJect Syringe | Ocuject, LLC | Sep 8, 2023 | SESE |
| [K200242](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY/K200242.md) | StaClear Syringe | Tribofilm Research, Inc. | Jul 27, 2020 | SESE |

## Top Applicants

- Staclear, Inc. — 2 clearances
- Altaviz, LLC — 1 clearance
- Congruence Medical Solutions, LLC — 1 clearance
- Hangzhou Sightnovo Medical Technology Co., Ltd. — 1 clearance
- Ocuject, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QLY)

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