Cleared Traditional

BLADEWORKS MICROKERATOME BLADE, MODEL 7061

K020079 · Blade Works, Inc. · Ophthalmic

Apr 2002

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K020079 is an FDA 510(k) clearance for the BLADEWORKS MICROKERATOME BLADE, MODEL 7061, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Blade Works, Inc. (San Marcos, US). The FDA issued a Cleared decision on April 19, 2002, 99 days after receiving the submission on January 10, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K020079 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2002
Decision Date	April 19, 2002
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement