Cleared Traditional

VitreJect Syringe

K230372 · Ocuject, LLC · General Hospital

Sep 2023

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K230372 is an FDA 510(k) clearance for the VitreJect Syringe, a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on September 8, 2023, 207 days after receiving the submission on February 13, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K230372 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2023
Decision Date	September 08, 2023
Days to Decision	207 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QLY — Ophthalmic Syringe
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5860
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.