Cleared Traditional

Altaviz Intravitreal Syringe

K243322 · Altaviz, LLC · General Hospital

May 2025

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K243322 is an FDA 510(k) clearance for the Altaviz Intravitreal Syringe, a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Altaviz, LLC (Irvine, US). The FDA issued a Cleared decision on May 9, 2025, 198 days after receiving the submission on October 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243322 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 2024
Decision Date	May 09, 2025
Days to Decision	198 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.