Cleared Special

KONAN SPECULAR MICROSCOPE XIV

K120264 · Konan Medical, Inc. · Ophthalmic
Apr 2012
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K120264 is an FDA 510(k) clearance for the KONAN SPECULAR MICROSCOPE XIV, a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Konan Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 11, 2012, 72 days after receiving the submission on January 30, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K120264 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2012
Decision Date April 11, 2012
Days to Decision 72 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NQE — Microscope, Specular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850
Definition Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.