Cleared Traditional

MILLENIUM MICROKERATOME, MODEL IMD-001

K992687 · Industrial & Medical Design, Inc. · Ophthalmic

Sep 1999

Decision

45d

Days

Class 1

Risk

About This 510(k) Submission

K992687 is an FDA 510(k) clearance for the MILLENIUM MICROKERATOME, MODEL IMD-001, a Keratome, Battery-powered (Class I — General Controls, product code HMY), submitted by Industrial & Medical Design, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 24, 1999, 45 days after receiving the submission on August 10, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K992687 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 1999
Decision Date	September 24, 1999
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF