QLY

Ophthalmic Syringe

Product code
QLY
Device name
Ophthalmic Syringe
Device class
Class 2
21 CFR
21 CFR 880.5860
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5
Summaries archived here
5 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification definition

An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-11-21.

NumberDecision dateApplicantDevice nameSummary
K2518492025-11-21Staclear, Inc.StaClear Syringe (SC250AN); StaClear Syringe (SC250LPDF
K2433222025-05-09Altaviz, LLCAltaviz Intravitreal SyringePDF
K2430272025-04-08Hangzhou Sightnovo Medical Technology Disposable Aqueous Humor Collector (SnovoDAHC I-50, PDF
K2439362025-04-03Staclear, Inc.StaClear Syringe (SC250AN); StaClear Syringe (SC250LPDF
K2431492024-12-20Congruence Medical Solutions, LLCMicroliter Dosing Syringe (9, 20, 25, 37.5, 50 and 1PDF

5 summaries are archived here for direct download.

Official FDA classification page: QLY
Classification and pathway per current FDA publications. Data from openFDA (CC0).