Cleared Traditional

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

K052891 · Hawken Industries · Ophthalmic

Mar 2006

Decision

161d

Days

Class 1

Risk

About This 510(k) Submission

K052891 is an FDA 510(k) clearance for the HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Hawken Industries (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 23, 2006, 161 days after receiving the submission on October 13, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K052891 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2005
Decision Date	March 23, 2006
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF