Cleared Special

NONCON ROBO PACHY F&A

K062763 · Konan Medical, Inc. · Ophthalmic

Feb 2008

Decision

525d

Days

Class 2

Risk

About This 510(k) Submission

K062763 is an FDA 510(k) clearance for the NONCON ROBO PACHY F&A, 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 February 22, 2008, 525 days after receiving the submission on September 15, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K062763 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2006
Decision Date	February 22, 2008
Days to Decision	525 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.