Cleared Traditional

MICROKERATOME, MODEL MK-2000

K990900 · Nidek, Inc. · Ophthalmic
Sep 1999
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K990900 is an FDA 510(k) clearance for the MICROKERATOME, MODEL MK-2000, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on September 24, 1999, 190 days after receiving the submission on March 18, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K990900 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1999
Decision Date September 24, 1999
Days to Decision 190 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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