510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QLYClass II

Ophthalmic Syringe

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

QLY is the FDA product code for Ophthalmic Syringe, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QLY
Device name
Ophthalmic Syringe
FDA 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.
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code QLY

By decision year
7 clearances under product code QLY with a decision year between 2020 and 2025, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code QLY by decision year
YearClearances
20201
20231
20241
20254

Applicants with the most clearances

Product code QLY
Applicants holding the most 510(k) clearances under product code QLY
ApplicantClearances
Staclear, Inc.2
Altaviz, LLC1
Congruence Medical Solutions, LLC1
Hangzhou Sightnovo Medical Technology Co., Ltd.1
Ocuject, LLC1
Tribofilm Research, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code