Cleared Traditional

MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB

K022982 · Med-Logics, Inc. · Ophthalmic
Nov 2002
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K022982 is an FDA 510(k) clearance for the MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Med-Logics, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on November 15, 2002, 67 days after receiving the submission on September 9, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K022982 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2002
Decision Date November 15, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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