Cleared Special

Huvitz Imaging System

K191615 · Huvitz Co., Ltd. · Ophthalmic
Jul 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191615 is an FDA 510(k) clearance for the Huvitz Imaging System, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Huvitz Co., Ltd. (Anyang-Si, Dongan-Gu, KR). The FDA issued a Cleared decision on July 18, 2019, 30 days after receiving the submission on June 18, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K191615 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2019
Decision Date July 18, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050