Cleared Traditional

CellChek 20 rc

K203244 · Konan Medical, Inc. · Ophthalmic
Jun 2021
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K203244 is an FDA 510(k) clearance for the CellChek 20 rc, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Konan Medical, Inc. (Nishinomiya, JP). The FDA issued a Cleared decision on June 15, 2021, 224 days after receiving the submission on November 3, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K203244 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2020
Decision Date June 15, 2021
Days to Decision 224 days
Submission Type Traditional
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