Cleared Traditional

Non-Mydriatic Retinal Camera NW500

K221111 · Topcon Corporation · Ophthalmic
Aug 2022
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K221111 is an FDA 510(k) clearance for the Non-Mydriatic Retinal Camera NW500, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Topcon Corporation (Itabashi-Ku, JP). The FDA issued a Cleared decision on August 29, 2022, 136 days after receiving the submission on April 15, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K221111 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2022
Decision Date August 29, 2022
Days to Decision 136 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