Cleared Traditional

SP-1PSpecular Microscope

K142417 · Topcon Corporation · Ophthalmic
May 2015
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K142417 is an FDA 510(k) clearance for the SP-1PSpecular Microscope, a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 29, 2015, 274 days after receiving the submission on August 28, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K142417 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2014
Decision Date May 29, 2015
Days to Decision 274 days
Submission Type Traditional
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.