Cleared Traditional

Fundus Camera

K202097 · Huvitz Co., Ltd. · Ophthalmic
Feb 2021
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K202097 is an FDA 510(k) clearance for the Fundus Camera, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Huvitz Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on February 2, 2021, 188 days after receiving the submission on July 29, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K202097 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2020
Decision Date February 02, 2021
Days to Decision 188 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120