Cleared Traditional

BLADEWORKS MICROKERATOME BLADE

K993225 · Blade Works, Inc. · Ophthalmic

Mar 2000

Decision

175d

Days

Class 1

Risk

About This 510(k) Submission

K993225 is an FDA 510(k) clearance for the BLADEWORKS MICROKERATOME BLADE, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Blade Works, Inc. (Hillsboro, US). The FDA issued a Cleared decision on March 20, 2000, 175 days after receiving the submission on September 27, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K993225 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1999
Decision Date	March 20, 2000
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement