Cleared Traditional

K040373 - KERATO ANALYZER (EKA)
(FDA 510(k) Clearance)

K040373 · Konan Medical, Inc. · Ophthalmic

Mar 2004

Decision

31d

Days

Class 2

Risk

K040373 is an FDA 510(k) clearance for the KERATO ANALYZER (EKA), a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 19, 2004, 31 days after receiving the submission on February 17, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K040373 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2004
Decision Date	March 19, 2004
Days to Decision	31 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.