Cleared Traditional

VIA360? Surgical System

K243503 · New World Medical, Inc. · Ophthalmic
Feb 2025
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K243503 is an FDA 510(k) clearance for the VIA360? Surgical System, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on February 14, 2025, 94 days after receiving the submission on November 12, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K243503 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date February 14, 2025
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725