Product code QLY

Device name

Ophthalmic Syringe

Medical specialty

General Hospital

Device class

2

Regulation number

880.5860

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset