QYM — Ophthalmic Needle Class II

FDA Device Classification

Classification Details

Product Code: QYM
Device Class: Class II
Regulation Number: 880.5570
Submission Type
Review Panel: HO
Medical Specialty: General Hospital
Implant: No

Definition

An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K242073	tsk laboratory international japan	STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)	October 23, 2024
K230951	terumo europe n.v	Terumo Injection Filter Needle (NF-3013RBKE05M)	October 18, 2023