Cleared Traditional

EPIVISION SL SYSTEM

K072102 · Gebauer Medizintechnik GmbH · Ophthalmic

Jan 2009

Decision

535d

Days

Class 1

Risk

About This 510(k) Submission

K072102 is an FDA 510(k) clearance for the EPIVISION SL SYSTEM, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Gebauer Medizintechnik GmbH (Lexington, US). The FDA issued a Cleared decision on January 16, 2009, 535 days after receiving the submission on July 31, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K072102 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2007
Decision Date	January 16, 2009
Days to Decision	535 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF