FDA Product Code QLY: Ophthalmic Syringe
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.
Leading manufacturers include Staclear, Inc., Ocuject, LLC and Hangzhou Sightnovo Medical Technology Co., Ltd..
FDA 510(k) Cleared Ophthalmic Syringe Devices (Product Code QLY)
About Product Code QLY - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QLY since 2020, with 7 receiving FDA clearance (average review time: 160 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QLY have taken an average of 147 days to reach a decision - down from 193 days historically, suggesting improved FDA processing for this classification.
QLY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →