Cleared Traditional

Huvitz Imaging System

K161829 · Huvitz Co., Ltd. · Ophthalmic

Apr 2017

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K161829 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. (Gunpo-Si, KR). The FDA issued a Cleared decision on April 6, 2017, 275 days after receiving the submission on July 5, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K161829 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2016
Decision Date	April 06, 2017
Days to Decision	275 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF