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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5860
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K251849Staclear, Inc. · 510k2025-11-21
K243322Altaviz, LLC · 510k2025-05-09
K243027Hangzhou Sightnovo Medical Technology Co., Ltd. · 510k2025-04-08
K243936Staclear, Inc. · 510k2025-04-03
K243149Congruence Medical Solutions, LLC · 510k2024-12-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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